Colposcope (And Colpomicroscope)

FDA product code HEX · 52 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.1630
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-20 – 2024-06-14

HEX 2024-06-14

Smart Scope® CX

Applicant Periwinkle Technologies Pvt., Ltd.

K number K233043

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HEX 2019-05-08

Gynescope System

Applicant Illumigyn , Ltd.

K number K190187

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HEX 2018-11-27

Biop Digital Colposcope

Applicant Biop Medical , Ltd.

K number K182764

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HEX 2018-09-21

Pocket Colposcope System

Applicant Hadleigh Health Technologies, LLC

K number K181034

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HEX 2017-05-21

LT-300 SD Digital Video Colposcope

Applicant Lutech Industries, Inc.

K number K170446

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HEX 2016-12-19

EVA (Enhanced Visual Assessment) System

Applicant Mobileodt , Ltd.

K number K161871

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HEX 2016-09-14

Colposcope System

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K number K160341

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HEX 2016-05-13

LT-300 HD

Applicant Lutech Industries, Inc.

K number K160380

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HEX 2013-09-18

GC-3000E DIGITAL COLPOSCOPE

Applicant Shenzhen Goldcare Meditech Co., Ltd.

K number K122311

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HEX 2013-06-12

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE

Applicant Medgyn Products, Inc.

K number K122973

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HEX 2011-04-08

ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE

Applicant Sti Medical Systems, LLC

K number K110147

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HEX 2011-03-10

DYSIS

Applicant Forth Photonics Hellas SA

K number K092433

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HEX 2010-12-20

ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY

Applicant Sti Medical Systems

K number K090324

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HEX 2010-08-06

SEILER COLPOSCOPE, MODELS 935, 955 AND 985

Applicant Seiler Precision Microscopes

K number K101141

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HEX 2010-07-09

ECLERIS MICROSTAR COLPOSCOPE

Applicant Ecleris USA

K number K100595

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HEX 2008-01-31

CERVICAL MD, MODEL C10

Applicant Sti Medical Systems

K number K072691

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HEX 2007-11-15

COLPO-MASTER

Applicant United Products & Instruments, Inc.

K number K073053

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HEX 2007-10-12

SOUNMED COLOPOSCOPE COLPO-99/99PLUS

Applicant Sounmed, Inc.

K number K070845

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HEX 2006-08-07

CO-1000 COLPOSCOPE, MULTIPLE

Applicant Gynex Corp.

K number K061306

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HEX 2004-03-12

IMAGE MANAGEMENT SYSTEM

Applicant Welch Allyn, Inc.

K number K033870

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HEX 2003-12-19

MEDISCOPE

Applicant Sometech Corporation

K number K031436

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HEX 2003-08-22

INTERMED ZOOM COLPOSCOPE

Applicant Intermed Group, Inc.

K number K031639

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HEX 2003-02-10

GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000

Applicant Goldway Us, Inc.

K number K021153

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HEX 2002-10-25

DFV CPG COLPOSCOPE

Applicant D.F. Vasconcellos S.A.

K number K021854

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HEX 2000-07-25

MEDSCOPE

Applicant All-Pro Imaging Corp.

K number K001314

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HEX 2000-06-27

LEICA COLPOSCOPE

Applicant Leica Microscopy Systems , Ltd.

K number K000707

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HEX 1999-10-26

TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM

Applicant Circon Corp.

K number K992544

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HEX 1998-10-19

LEISEGANG VIDEO COLPOSCOPE

Applicant Netoptix Corp.

K number K981958

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HEX 1998-02-02

COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM

Applicant CooperSurgical, Inc.

K number K972630

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HEX 1997-04-22

IMT LOUPE-COLPOSCOPE

Applicant Inventive Medical Technology

K number K963593

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HEX 1996-05-07

VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND

Applicant Welch Allyn, Inc.

K number K955635

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HEX 1995-04-25

COLPOSCOPES AND ACCESSORIES

Applicant Leisegang Medical, Inc.

K number K940094

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HEX 1994-03-23

HM-0690 COLPOSCOPE

Applicant Hill-Med, Inc.

K number K932896

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HEX 1994-03-23

HM-0660

Applicant Hill-Med, Inc.

K number K932782

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HEX 1992-04-27

ACCUSCOPE(TM) & ACCUSCOPE II(TM)

Applicant Vineland Medical Products, Inc.

K number K913365

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HEX 1990-09-04

LM-1Z ZOOM SCOPE

Applicant Leisegang Medical, Inc.

K number K902313

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HEX 1990-07-27

ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002

Applicant Percutaneous Technologies

K number K903213

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HEX 1989-02-27

MALLEABLE PLACENTA CURETTE

Applicant Kinetic Medical Products

K number K890387

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HEX 1989-02-23

JEDMED KP6 COLPOSCOPE

Applicant Jedmed Instrument Co.

K number K884934

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HEX 1988-03-14

GYNESCOPE

Applicant Medgyn Products, Inc.

K number K880195

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HEX 1987-08-05

COLPOSTAR V-6

Applicant Wallach Surgical Devices, Inc.

K number K871683

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HEX 1987-08-05

PHOTOSTAR V-8

Applicant Wallach Surgical Devices, Inc.

K number K871681

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HEX 1987-06-24

WALLACH CONVERTIBLE COLPOSCOPE

Applicant Wallach Surgical Devices, Inc.

K number K871682

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HEX 1985-11-19

WALLACH ZOOM COLPOSCOPE

Applicant Wallach Surgical Devices, Inc.

K number K853389

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HEX 1985-10-23

OCS-2 COLPOSCOPE

Applicant Olympus Corp.

K number K852980

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HEX 1982-06-16

CERVISCOPE OPTICAL SYSTEM

Applicant Fotomedics, Inc.

K number K821616

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HEX 1980-08-13

KRYMED SYSTEM 4001 TILT SCOPE

Applicant Cryomedics, Inc.

K number K801730

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HEX 1979-09-17

KOLPOSKOP KP20005

Applicant Elmed, Inc.

K number K791279

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HEX 1977-06-03

COLPOSCOPE MODEL II

Applicant Dynatech Cryomedical Co.

K number K770896

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HEX 1977-05-20

COLPOSCOPE SYSTEM

Applicant Richard Wolf Medical Instruments Corp.

K number K770697

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HEX 1976-12-17

DYNATECH JD7/JD7P COLPOSCOPE

Applicant Dynatech Cryomedical Co.

K number K761205

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HEX 1976-10-20

COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I

Applicant Dynatech Cryomedical Co.

K number K760763

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