Hysteroscope (And Accessories)

FDA product code HIH · 168 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.1690
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-03-03 – 2026-09-25

HIH 2026-09-25

UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)

Applicant Karl Storz SE & CO. KG

K number K254252

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HIH 2026-09-18

UNIDRIVE Select System

Applicant Karl Storz SE & CO. KG

K number K261102

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HIH 2026-09-08

Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)

Applicant Zhejiang Geyi Medical Instrument Co., Ltd.

K number K254294

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HIH 2026-08-18

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

Applicant Axora Medical, Inc.

K number K260984

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HIH 2026-06-04

Strauss Surgical Resection Instruments

Applicant American Medical Endoscopy, Inc.

K number K253020

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HIH 2026-05-15

Manual Tissue Removal Device

Applicant Suzhou AcuVu Medical Technology Co., Ltd.

K number K254050

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HIH 2026-02-26

InnovexView (GC146-17, GC150-20, GC155-23)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K number K254251

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HIH 2025-12-18

ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

Applicant Jiangsu Jiyuan Medical Technology Co., Ltd.

K number K252793

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HIH 2025-07-18

SPY Cystoscope/Hysteroscope

Applicant Stryker Endoscopy

K number K252012

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HIH 2025-06-03

RZ Resectoscope System

Applicant Rz Medizintechnik GmbH

K number K243382

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HIH 2024-08-16

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

Applicant MacroLux Medical Technology Co., Ltd.

K number K240978

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HIH 2024-08-02

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K number K241987

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HIH 2024-07-26

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

Applicant Origyn Medical Technology (Hangzhou) Co., Ltd.

K number K240401

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HIH 2024-03-05

HTx Disposable Hysteroscope System

Applicant Suzhou AcuVu Medical Technology Co., Ltd.

K number K231260

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HIH 2024-02-12

SPY Cystoscope/Hysteroscope

Applicant Stryker Endoscopy

K number K233635

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HIH 2024-02-12

Endoscopic Video Image Processor, Single-Use Video Hysteroscope

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K number K232003

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HIH 2023-11-30

Benesta Tissue Removal Device

Applicant Caldera Medical, Inc.

K number K233500

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HIH 2023-09-14

HOPKINS Telescopes

Applicant Karl Storz Endoscopy America, Inc.

K number K223885

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HIH 2023-08-21

Aveta System 2.0

Applicant Meditrina, Inc.

K number K223813

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HIH 2023-04-27

UNIDRIVE SIII System

Applicant Karl Storz-Endoscopy-America, Inc.

K number K223520

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HIH 2022-09-02

Visera Hysterovideoscope Olympus HYF Type V

Applicant Olympus Medical Systems Corporation

K number K221557

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HIH 2022-05-26

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Applicant Meditrina, Inc.

K number K213171

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HIH 2021-12-22

Sheath, Stopcock Accessory

Applicant Olympus Winter & Ibe GmbH

K number K213207

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HIH 2021-11-23

Hystero-V Hysteroscope

Applicant Hysterovue, Inc.

K number K202445

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HIH 2021-10-01

Medical Endoscope Image Processing System

Applicant Jiangsu Jiyuan Medical Technology Co., Ltd.

K number K210270

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HIH 2021-09-15

HTx Disposable Hysteroscope System

Applicant Acuvu, Inc.

K number K211227

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HIH 2020-10-23

BenestaTM Tissue Removal Device

Applicant Caldera Medical, Inc.

K number K192811

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HIH 2020-10-08

Schoelly Cystoscopes/Hysteroscopes and Accessories

Applicant Schoelly Fiberoptic GmbH

K number K201970

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HIH 2020-09-25

Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent

Applicant Stryker Sustainability Solutions

K number K201756

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HIH 2020-09-09

Benesta Hysteroscope

Applicant Caldera Medical, Inc.

K number K192822

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HIH 2020-02-05

Endosee System

Applicant CooperSurgical, Inc.

K number K200038

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HIH 2020-01-17

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

Applicant Lina Medical Aps

K number K193007

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HIH 2020-01-16

Resectr Tissue Resection Device

Applicant Boston Scientific Corporation

K number K191538

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HIH 2019-12-19

Aveta Disposable Hysteroscope

Applicant Meditrina, Inc.

K number K192100

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HIH 2019-11-18

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

Applicant Reed Medical (Zhejiang) Co., Ltd.

K number K190797

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HIH 2019-11-01

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

Applicant Uvision360, Inc.

K number K192278

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HIH 2019-10-01

Aveta System

Applicant Meditrina, Inc.

K number K191958

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HIH 2019-08-29

Omni Hysteroscope, Omni Lok cervical seal

Applicant Hologic, Inc.

K number K191281

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HIH 2019-06-06

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K number K191335

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HIH 2019-06-06

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

Applicant Uvision360, Inc.

K number K190827

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HIH 2019-05-21

MAKO 7

Applicant Boston Scientific Corporation

K number K182975

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HIH 2019-05-16

Aveta System

Applicant Meditrina, Inc.

K number K190372

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HIH 2019-05-15

Endosee System

Applicant CooperSurgical, Inc.

K number K190639

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HIH 2019-05-10

Hysteroscope System

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K number K181545

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HIH 2019-04-24

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K number K190113

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HIH 2019-01-31

Endosee System

Applicant CooperSurgical, Inc.

K number K183020

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HIH 2019-01-04

Polygon Resection Device

Applicant Polygon Medical, Inc.

K number K182675

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HIH 2018-12-06

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

Applicant Hologic, Inc.

K number K182006

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HIH 2018-08-29

TruClear Elite Hysteroscope

Applicant Covidien

K number K180496

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HIH 2018-08-23

MyoSure XL Tissue Removal Device for Fluent

Applicant Hologic, Inc.

K number K181974

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HIH 2018-07-25

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

Applicant Corinth Medtech, Inc.

K number K180752

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HIH 2018-06-08

HSW Resection Instruments

Applicant Henke-Sass, Wolf GmbH

K number K173070

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HIH 2018-05-08

MyoSure MANUAL Tissue Removal Device

Applicant Hologic, Inc.

K number K173901

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HIH 2018-04-16

GDT-1000 System

Applicant Acuvu, Inc.

K number K180096

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HIH 2018-01-04

LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

Applicant Lina Medical Aps

K number K171113

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HIH 2017-09-20

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

Applicant Hologic, Inc.

K number K172566

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HIH 2017-07-13

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

Applicant CooperSurgical, Inc.

K number K170660

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HIH 2016-11-22

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device

Applicant Smith & Nephew, Inc.

K number K161763

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HIH 2016-06-14

Symphion Endoscope and Symphion Cervical Sheath

Applicant Boston Scientific

K number K160751

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HIH 2016-06-09

MAKO 7

Applicant Nvision Medical Corporation

K number K160510

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HIH 2013-12-13

TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS

Applicant Smith & Nephew, Inc.

K number K132015

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HIH 2013-08-22

MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)

Applicant Hologic, Inc.

K number K131736

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HIH 2013-08-22

MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)

Applicant Hologic, Inc.

K number K131581

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HIH 2013-03-19

IOGYN ENDOSCOPE

Applicant Iogyn, Inc.

K number K123330

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HIH 2013-03-08

ENDOSEE MODEL 8000 U-SCOPE

Applicant Endosee Corp

K number K123151

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HIH 2012-09-19

MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL

Applicant Hologic, Inc.

K number K122563

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HIH 2012-09-10

MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

Applicant Hologic, Inc.

K number K122498

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HIH 2012-07-19

MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)

Applicant Hologic, Inc.

K number K121868

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HIH 2012-03-23

MYOSURE CONTROL UNIT

Applicant Hologic, Inc.

K number K120593

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HIH 2011-11-22

TRUCLEAR OPERATIVE HYSTEROSCOPE

Applicant Smith & Nephew, Inc.

K number K112134

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HIH 2011-03-30

TRUCLEAR MORCELLATOR SYSTEM

Applicant Smith & Nephew, Inc.

K number K110038

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HIH 2011-03-25

TRUCLEAR INCISOR PLUS BLADE 2.9

Applicant Smith & Nephew, Inc.

K number K103389

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HIH 2010-10-15

MYOSURE ROD LENS SCOPE SEALS

Applicant Interlace Medical, Inc.

K number K102686

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HIH 2010-05-18

FEMEYE TWO

Applicant Fem Suite, LLC

K number K093218

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HIH 2010-03-30

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Applicant Interlace Medical, Inc.

K number K100559

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HIH 2010-02-12

ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC

Applicant Gimmi GmbH

K number K092421

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HIH 2009-12-04

OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK

Applicant Obp Medical

K number K091838

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HIH 2009-10-23

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Applicant Interlace Medical, Inc.

K number K091100

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HIH 2009-09-29

GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4

Applicant Gyrus Acmi, Inc.

K number K092278

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HIH 2009-08-21

MYOSURE ROD LENS HYSTEROSCOPE

Applicant Interlace Medical, Inc.

K number K091465

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HIH 2008-07-23

INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM

Applicant Interlace Medical, Inc.

K number K081070

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HIH 2008-04-17

INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM

Applicant Interlace Medical, Inc.

K number K073690

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HIH 2007-11-16

FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM

Applicant Vision-Sciences, Inc.

K number K071127

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HIH 2006-03-31

OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL

Applicant Optivia Medical, LLC

K number K053583

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HIH 2004-10-07

IUR RECIPROCATING MORCELLATOR MODEL # 7210517

Applicant Smith & Nephew, Inc.

K number K041774

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HIH 2004-05-17

STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM

Applicant Stryker Endoscopy

K number K040390

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HIH 2004-03-09

VERSAPOINT RESECTOSCOPIC SYSTEM

Applicant Gynecare, A Div. of Ethicon, Inc.

K number K040302

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HIH 2003-12-23

UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753

Applicant Richard Wolf Medical Instruments Corp.

K number K033113

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HIH 2003-12-02

SMITH & NEPHEW IUR MORCELLATION SYSTEM

Applicant Smith & Nephew, Inc.

K number K031787

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HIH 2003-09-29

ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0

Applicant Asap Endoscopic Products GmbH

K number K031974

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HIH 2003-01-24

VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

Applicant Olympus Optical Co., Ltd.

K number K022445

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HIH 2002-08-22

ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC

Applicant Acmi Corporation

K number K022480

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HIH 2002-03-11

GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25

Applicant Gimmi GmbH

K number K012869

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HIH 2002-01-17

SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224

Applicant Smith & Nephew, Inc.

K number K013870

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HIH 2001-07-22

HYSTEROSCOPES

Applicant Global Endoscopy, Inc.

K number K003802

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HIH 2000-08-22

KSEA MONOPOLAR VAPORIZATION ELECTRODES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K001740

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HIH 2000-05-26

HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241

Applicant Richard Wolf Medical Instruments Corp.

K number K000673

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HIH 2000-01-24

VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)

Applicant ETHICON, Inc.

K number K994418

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HIH 2000-01-18

GYNECARE VERSAPOINT G-VAP ELECTRODE

Applicant Gynecare, Inc.

K number K992901

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HIH 1999-12-03

GYRUS HYSTEROSCOPIC RESECTOSCOPE

Applicant Gyrus Medical , Ltd.

K number K993749

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