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Biopsy Needle

FDA product code FCG · 124 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1075
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-29 – 2025-10-24

FCG 2025-10-24

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Applicant Olympus Medical Systems Corp.

K number K252646

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FCG 2025-08-21

ClearTip FNA and FNB Types

Applicant Finemedix Co., Ltd.

K number K250994

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FCG 2024-07-29

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)

Applicant Cook Ireland, Ltd.

K number K241209

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FCG 2023-08-28

Precision GI

Applicant Limaca Medical, Ltd.

K number K231422

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FCG 2023-06-30

ClearTip

Applicant Finemedix Co., Ltd.

K number K231267

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FCG 2023-05-30

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)

Applicant Cook Ireland, Ltd.

K number K230909

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FCG 2023-03-29

EndoDrill® Model X

Applicant Bibbinstruments AB

K number K212423

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FCG 2022-07-06

Disposable Coaxial Biopsy Needle

Applicant Suzhou Leapmed Healthcare Corporation

K number K212822

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FCG 2022-07-06

Disposable Biopsy Refill Needle

Applicant Suzhou Leapmed Healthcare Corporation

K number K212819

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FCG 2021-05-20

EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

Applicant Cook Ireland, Ltd.

K number K210476

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FCG 2020-01-29

Biopsy Needle

Applicant Ushare Medical, Inc.

K number K191472

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FCG 2018-12-18

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

Applicant Apriomed AB

K number K181756

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FCG 2018-11-15

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

Applicant Olympus Medical Systems Corp.

K number K180668

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FCG 2018-11-01

Clear-Tip EUS-FNA

Applicant Finemedix Co., Ltd.

K number K180363

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FCG 2018-10-31

Single Use Aspiration Needle NA-U201H

Applicant Olympus Medical Systems Corp.

K number K181994

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FCG 2018-06-08

Single Use Aspiration Needle NA-U200H

Applicant Olympus Medical Systems Corp.

K number K180449

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FCG 2018-04-26

Beacon EUS Access System

Applicant Covidien, LLC

K number K180037

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FCG 2017-12-12

Sterile Endoscope Biopsy Sampling Needle

Applicant Changzhou Detain Medical Devices Co., Ltd.

K number K171956

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FCG 2017-08-04

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

Applicant Wilson-Cook Medical, Inc.

K number K171596

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FCG 2017-06-14

Howell Biliary Introducer Needle

Applicant Wilson-Cook Medical, Inc.

K number K160890

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FCG 2016-09-02

Perineologic Access Needle

Applicant Corbin Clinical Resources, LLC

K number K160423

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FCG 2016-03-22

Single Use Aspiration Needle NA-U401SX

Applicant Olympus Medical Systems Corp.

K number K160098

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FCG 2016-03-21

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle

Applicant Cook Ireland, Ltd.

K number K160229

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FCG 2013-11-20

BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,

Applicant Beacon Endoscopic

K number K133008

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FCG 2011-07-27

TISSUE SAMPLING NEEDLE

Applicant United States Endoscopy Group, Inc.

K number K103694

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FCG 2010-12-30

BNX FINE NEEDLE ASPIRATION SYSTEM

Applicant Boston Endoscopic Engineering

K number K103668

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FCG 2010-03-30

RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

Applicant Boston Scientific Corporation

K number K100712

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FCG 2010-01-21

ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O

Applicant Cook Ireland, Ltd.

K number K093195

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FCG 2009-11-02

ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A

Applicant Cook Ireland, Ltd.

K number K092359

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FCG 2009-05-08

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM

Applicant Medi-Globe Corporation

K number K091257

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FCG 2009-03-20

SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025

Applicant Medi-Globe Corporation

K number K083802

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FCG 2009-02-06

ECHOTIP ULTRA ULTRASOUND NEEDLE

Applicant Cook Endoscopy

K number K083330

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FCG 2008-07-22

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

Applicant B-K Medical Aps

K number K081323

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FCG 2007-12-21

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

Applicant Envisioneering, LLC

K number K073399

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FCG 2007-05-30

THYROSAMPLER

Applicant Acd Medical Innovation Corp.

K number K062979

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FCG 2007-03-07

TROKABONE, TROKABONE STERNAL

Applicant PAJUNK GmbH Medizintechnologie

K number K070179

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FCG 2007-01-31

SONOTIP II ULTRASOUND NEEDLE SYSTEM

Applicant Medi-Globe Corporation

K number K070129

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FCG 2005-07-27

MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY

Applicant Sterylab S.R.L.

K number K051506

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FCG 2005-07-13

K-C HEMOSTATIC BIOPSY SYSTEM

Applicant Bioengineering Consultants , Ltd.

K number K050135

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FCG 2005-06-16

SONOTIP II ULTRASOUND NEEDLE SYSTEM

Applicant Medi-Globe Corp.

K number K051247

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FCG 2005-05-12

SINGLE USE ASPIRATION NEEDLE NA-201SX-4022

Applicant Olympus Medical Systems Corporation

K number K050503

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FCG 2005-02-08

EASY CORE BIOPSY SYSTEM II

Applicant Boston Scientific Corp

K number K050120

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FCG 2004-05-06

EASY CORE BIOPSY SYSTEM

Applicant Boston Scientific Corp

K number K040893

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FCG 2003-01-15

MODIFICATION TO TEMNO BIOPSY NEEDLES

Applicant Allegiance Healthcare Corp.

K number K024120

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FCG 2002-12-23

DISPOSABLE ASPIRATION NEEDLE NA-200H

Applicant The Olympus Optical Co.

K number K023272

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FCG 2002-09-03

BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES

Applicant Biopsy Sciences, LLC

K number K021847

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FCG 2002-07-12

TOPCUT

Applicant H.S. Hospital Service S.R.L.

K number K021525

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FCG 2002-03-12

SONOPSY

Applicant Hakko Medical Co., Ltd.

K number K013109

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FCG 2001-12-12

SECURCUT ASPIRATION BIOPSY NEEDLE

Applicant H.S. Hospital Services S.P.A.

K number K013071

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FCG 2001-12-12

JAMSHIDI BIOPSY NEEDLE

Applicant H.S. Hospital Services S.P.A.

K number K013070

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FCG 2001-12-12

BIOSPEED

Applicant H.S. Hospital Services S.P.A.

K number K013069

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FCG 2001-10-24

INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836

Applicant Boston Scientific Corp

K number K012864

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FCG 2001-10-19

WILSON-COOK ULTRASOUND BIOPSY NEEDLE

Applicant Wilson-Cook Medical, Inc.

K number K013356

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FCG 2001-10-15

CHIBA NEEDLE

Applicant Ispg, Inc.

K number K012358

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FCG 2001-06-27

EASYBELL

Applicant Biopsybell S.A.S.

K number K011075

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FCG 2001-06-22

AUTOMATED CORE BIOPSY DEVICE

Applicant Promex, Inc.

K number K011270

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FCG 2000-12-19

BIOMOL ASPIRATION BIOPSY NEEDLE

Applicant H.S. Hospital Service S.R.L.

K number K002947

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FCG 2000-12-19

SILENT BIOPSY NEEDLE

Applicant H.S. Hospital Service S.R.L.

K number K002946

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FCG 2000-12-19

PRECISA BIOPSY NEEDLE

Applicant H.S. Hospital Service S.R.L.

K number K002944

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FCG 1999-11-03

OLYMPUS NA-10J-KB ASPIRATION NEEDLE

Applicant Olympus America, Inc.

K number K991672

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FCG 1999-03-31

MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

Applicant Medi-Globe Corp.

K number K990220

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FCG 1998-11-06

N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE

Applicant Avid N.I.T., Inc.

K number K983218

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FCG 1998-07-31

WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE

Applicant Worldwide Medical Technologies, LLC

K number K981889

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FCG 1997-07-14

MRI NEEDLES

Applicant Cook, Inc.

K number K963565

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FCG 1997-06-20

COAXIAL NEEDLE

Applicant United States Endoscopy Group, Inc.

K number K971842

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FCG 1997-04-11

OLYMPUS NA-10J-1 ASPIRATION NEEDLE

Applicant Olympus America, Inc.

K number K970563

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FCG 1997-03-11

SMARTGUIDE

Applicant Ferguson Medical

K number K963894

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FCG 1997-01-29

WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE

Applicant Wilson-Cook Medical, Inc.

K number K961897

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FCG 1996-11-27

ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE

Applicant Gallini Intl., Inc.

K number K962570

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FCG 1996-11-27

BIOMID BONE MARROW BIOPSY NEEDLE

Applicant Gallini Intl., Inc.

K number K962569

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FCG 1996-11-25

ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES

Applicant Gallini Intl., Inc.

K number K962568

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FCG 1996-10-11

TX BIOPSY NEEDLE

Applicant Gallini S.R.L.

K number K962905

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FCG 1996-04-30

DAUM BIOPSYNEEDLE

Applicant Ferguson Medical

K number K961185

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FCG 1996-03-15

LAURUS NEEDLE CORE BIOPSY SYSTEM

Applicant Laurus Medical Corp.

K number K960317

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FCG 1995-12-20

3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY

Applicant Olympus America, Inc.

K number K943304

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FCG 1995-11-16

GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES

Applicant Global Medical Products, Ltd.

K number K951421

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FCG 1995-10-07

PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM

Applicant Promedical , Ltd.

K number K954596

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FCG 1995-09-22

AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT

Applicant Promex, Inc.

K number K954231

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FCG 1995-09-12

GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE

Applicant Promex, Inc.

K number K954155

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FCG 1995-05-22

FNA BIOPSY NEEDLE

Applicant Betta Medical, Inc.

K number K941722

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FCG 1995-04-21

PRO-B BIOPSY NEEDLE

Applicant Promedical , Ltd.

K number K951598

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FCG 1995-04-04

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE

Applicant B. Braun of America, Inc.

K number K950982

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FCG 1995-03-06

RUTNER BIOPSY DEVICE

Applicant Cook Urological, Inc.

K number K950810

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FCG 1995-02-13

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA

Applicant Medi-Globe Corp.

K number K935844

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FCG 1995-02-07

BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K945813

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FCG 1995-02-01

ECHO STAR NEEDLE SET

Applicant Ideamatrix

K number K945921

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FCG 1994-12-21

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE

Applicant Promex, Inc.

K number K945146

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FCG 1994-12-21

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE

Applicant Promedical , Ltd.

K number K944944

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FCG 1994-11-09

MODIFIED BIOPSY NEEDLE

Applicant Biopsys Medical, Inc.

K number K945133

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FCG 1994-09-26

THE BIOPSY TOOL

Applicant Citation Medical Corp.

K number K941563

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FCG 1994-03-28

GLOBAL MEDICAL CUTTING BIOPSY NEEDLE

Applicant Global Medical Prods, Inc.

K number K934256

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FCG 1994-03-22

COAXIAL BIOPSY NEEDLE

Applicant Bard Gynecology and Radiology

K number K936194

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FCG 1994-03-11

BIP-COAX-SYSTEM

Applicant Uni-Quatro Industries Canada, Inc.

K number K915801

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FCG 1994-03-07

BIP BIOPSY NEEDLE MODIFICATION

Applicant Bip USA, Inc.

K number K934370

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FCG 1994-01-07

WILSON-COOK GI ASPIRATION NEEDLE

Applicant Wilson-Cook Medical, Inc.

K number K934356

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FCG 1993-03-22

PROACT BIOPSY NEEDLE ENCHANCEMENTS

Applicant Proact, Ltd.

K number K926559

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FCG 1992-11-23

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES

Applicant Core Medical, Inc.

K number K924271

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FCG 1992-01-07

CORE MEDICAL BIOPSY NEEDLE

Applicant Core Medical, Inc.

K number K914732

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FCG 1991-06-10

BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER

Applicant C.R. Bard, Inc.

K number K910720

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FCG 1991-05-20

HYPODERMIC NEEDLES, SINGLE LUMEN

Applicant Popper & Sons, Inc.

K number K911397

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