Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Instrument, Biopsy

FDA product code KNW · 347 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1075
Review panel: SU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-01 – 2026-08-28

KNW 2011-07-29

MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-

Applicant Insert Molding Solutions, Inc.

K number K111529

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KNW 2011-06-24

BIOPSY HANDY, MRI BIOPSY HANDY

Applicant Somatex Medical Technologies GmbH

K number K102771

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KNW 2011-06-16

ENCOR ENSPIRE BREAST BIOPSY SYSTEM

Applicant C.R. Bard, Inc.

K number K111100

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KNW 2011-06-08

J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA

Applicant Busse Hospital Disposables

K number K110883

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KNW 2011-05-27

MEDAX UNIPERSONALE SRL

Applicant Medax Unipersonale Srl

K number K092338

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KNW 2010-12-27

FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)

Applicant C.R. Bard, Inc.

K number K103359

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KNW 2010-08-27

BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

Applicant Medical Device Technologies, Inc.

K number K101832

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KNW 2010-04-29

MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING

Applicant Ethicon Endo-Surgery, LLC

K number K093899

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KNW 2009-11-20

ENCOR BREAST BIOPSY SYSTEM

Applicant Senorx, Inc.

K number K093512

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KNW 2009-11-19

PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520

Applicant Inrad

K number K093399

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KNW 2009-11-17

SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018

Applicant Inrad

K number K093256

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KNW 2009-11-10

FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US

Applicant C.R. Bard, Inc.

K number K093068

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KNW 2009-09-24

RP CUTTING NEEDLE

Applicant Riverpoint Medical

K number K092059

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KNW 2009-06-04

REVOLUTION FULL CORE BIOPSY

Applicant Inrad

K number K090611

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KNW 2008-10-15

VACORA VACUUM ASSISTED BIOPSY SYSTEM

Applicant C.R. Bard, Inc.

K number K082681

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KNW 2008-06-17

INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL

Applicant Intact Medical Corporation

K number K081057

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KNW 2008-04-11

CORAMATE/SPIROTOME SYSTEM

Applicant Medinvents

K number K080095

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KNW 2008-03-06

SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012

Applicant Sanarus Medical, Inc.

K number K080171

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KNW 2007-10-22

ONCONTROL BONE MARROW BIOPSY SYSTEM

Applicant Vidacare Corporation

K number K072045

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KNW 2007-10-16

LIGHT SABRE SPINAL ACCESS DEVICE

Applicant Minrad, Inc.

K number K071814

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KNW 2007-05-15

RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537

Applicant Rubicor Medical, Inc.

K number K071048

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KNW 2007-04-30

DELTACUT (APPARATUS AND CANNULA)

Applicant PAJUNK GmbH Medizintechnologie

K number K063233

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KNW 2007-04-18

COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208

Applicant Cardinal Health, Inc.

K number K070091

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KNW 2007-02-14

SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT

Applicant PAJUNK GmbH Medizintechnologie

K number K063697

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KNW 2006-10-20

VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138

Applicant C.R. Bard, Inc.

K number K062832

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KNW 2006-07-13

CORAMATE/SPIROTOME SYSTEM

Applicant Medinvents

K number K060384

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KNW 2006-07-03

I-STYLE BONE MARROW ASPIRATION NEEDLE

Applicant Busse Hospital Disposables, Inc.

K number K061570

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KNW 2006-04-27

INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

Applicant Intact Medical Corporation

K number K060413

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KNW 2005-11-18

RUBICOR MAGIC BREAST BIOPSY DEVICE

Applicant Rubicor Medical, Inc.

K number K053151

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KNW 2005-11-07

ABBOTT SPINE, INC. SPINNAKER SYSTEM

Applicant Abbott Spine, Inc.

K number K052638

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KNW 2005-11-03

PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS

Applicant Pneumrx, Inc.

K number K052435

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KNW 2005-11-01

MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE

Applicant Manan Medical Products, Inc.

K number K052802

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KNW 2005-07-27

SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000

Applicant Sanarus Medical, Inc.

K number K051581

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KNW 2005-06-16

EASY CORE DETACHABLE BIOPSY SYSTEM

Applicant Boston Scientific Corp

K number K051361

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KNW 2005-06-03

IMBIBE BONE MARROW ASPIRATION NEEDLE

Applicant Orthovita, Inc.

K number K050795

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KNW 2005-05-16

ENCOR 7 GAUGE

Applicant Senorx, Inc.

K number K051158

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KNW 2005-02-11

INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE

Applicant Medical Device Technologies, Inc.

K number K043523

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KNW 2004-11-08

MAMMOTOME MR BIOPSY SYSTEM

Applicant Ethicon Endo-Surgery, Inc.

K number K042753

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KNW 2004-10-06

VACUUM ASSISTED CORE BIOPSY DEVICE

Applicant Suros Surgical Systems, Inc.

K number K042290

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KNW 2004-09-30

V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

Applicant Medical Device Technologies, Inc.

K number K042464

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KNW 2004-09-08

SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

Applicant Sanarus Medical, Inc.

K number K042136

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KNW 2004-09-08

VACUUM ASSISTED CORE BIOPSY DEVICE

Applicant Suros Surgical Systems, Inc.

K number K034021

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KNW 2004-07-22

COOK SIDEARM CORE TISSUE BIOPSY DEVICE

Applicant Urological, Inc.

K number K041544

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KNW 2004-07-09

CORE NEEDLE BIOPSY

Applicant Remington Medical, Inc.

K number K040266

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KNW 2004-04-30

SENORX BIOPSY DEVICE II

Applicant Senorx, Inc.

K number K040842

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KNW 2004-04-01

RABBIT

Applicant Scion International, Inc.

K number K040087

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KNW 2004-03-01

TRAPMATIC SYSTEM SET

Applicant H.S Hospital Service S.P.A

K number K033616

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KNW 2004-02-20

MAMMOTOME EX HAND HELD SYSTEM

Applicant Ethicon Endo-Surgery, Inc.

K number K033700

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KNW 2003-12-17

STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS

Applicant Stryker Corp.

K number K032943

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KNW 2003-11-10

MODIFICATION TO EN-BLOC BIOPSY SYSTEM

Applicant Neothermia Corp.

K number K033427

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KNW 2003-10-09

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM

Applicant Sanarus Medical, Inc.

K number K032506

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KNW 2003-10-09

MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM

Applicant Ethicon Endo-Surgery, Inc.

K number K030472

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KNW 2003-09-26

EXCISOR BIOPTOME, MODEL 01-0004

Applicant Acueity, Inc.

K number K032847

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KNW 2003-05-23

RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE

Applicant Ranfac, Corp.

K number K031344

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KNW 2003-05-09

MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

Applicant Nastech Pharmaceutical Company, Inc.

K number K030443

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KNW 2003-03-11

VACUFLASH BIOPSY SYSTEM

Applicant Bip USA, Inc.

K number K024089

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KNW 2002-12-11

SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE

Applicant Senorx, Inc.

K number K023923

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KNW 2002-10-11

ENCIRCLE LOCALIZATION DEVICE

Applicant Vivant Medical, Inc.

K number K022286

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KNW 2002-09-23

MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY

Applicant Sanarus Medical, Inc.

K number K022879

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KNW 2002-09-23

NAFD 100

Applicant Neomatrix, LLC

K number K020848

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KNW 2002-08-14

SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS

Applicant Senorx, Inc.

K number K021707

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KNW 2002-07-25

CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES

Applicant Parallax Medical, Inc.

K number K022169

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KNW 2002-06-26

SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM

Applicant Sanarus Medical, Inc.

K number K021137

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KNW 2002-06-25

BMN I TYPE MARROW ASPIRATION NEEDLE

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

K number K020987

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KNW 2002-05-20

BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL

Applicant Worldwide Medical Technologies, LLC

K number K020867

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KNW 2002-04-04

BIOSUC

Applicant Hakko Medical Co., Ltd.

K number K013108

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KNW 2002-04-03

CARIS MINITOME BIOPSY INSTRUMENT

Applicant Artemis Medical, Inc.

K number K020024

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KNW 2002-02-05

TRAPSYSTEM SET

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

K number K013692

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KNW 2001-12-18

NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT

Applicant Nastech Pharmaceutical Company, Inc.

K number K012088

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KNW 2001-09-12

ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE

Applicant Senorx, Inc.

K number K012023

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KNW 2001-08-22

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW

Applicant Ranfac, Corp.

K number K012224

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KNW 2001-08-17

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022

Applicant Imagyn Surgical

K number K011575

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KNW 2001-08-17

SPEEDYBELL

Applicant Biopsybell S.A.S.

K number K010735

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KNW 2001-07-24

VACUUM ASSISTED CORE BIOPSY DEVICE

Applicant Promex, Inc.

K number K010400

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KNW 2001-07-18

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES

Applicant Parallax Medical, Inc.

K number K011206

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KNW 2001-05-31

OSTEOBELL

Applicant Biopsybell S.A.S.

K number K011104

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KNW 2001-05-03

SANARUS CORE TISSUE BIOPSY SYSTEM

Applicant Endocare, Inc.

K number K003528

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KNW 2001-03-22

DAUM DOUBLE-SHOOT BISOPSY GUN

Applicant Daum GmbH

K number K010037

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KNW 2001-01-18

MAMMOTOME HAND HELD PROBE, MODEL MHH8

Applicant Ethicon Endo-Surgery, Inc.

K number K003297

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KNW 2000-12-15

VIVANT BREAST LESION LOCALIZATION DEVICE

Applicant Vivant Medical, Inc.

K number K003439

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KNW 2000-11-22

JAMSHIDI MARROW ACQUISITION CRADLE

Applicant Allegiance Healthcare Corp.

K number K003370

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KNW 2000-10-31

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE

Applicant CIVCO Medical Instruments Co., Inc.

K number K002546

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KNW 2000-05-01

BONE BIOPSY NEEDLE

Applicant Promex, Inc.

K number K001132

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KNW 2000-04-24

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

Applicant Inrad

K number K000612

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KNW 2000-04-10

PRO.DUCT CATHETER, MODEL CTH03

Applicant Pro. Duct Health, Inc.

K number K000135

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KNW 2000-01-07

AUTOMATED CORE BIOPSY DEVICE

Applicant Promex, Inc.

K number K994272

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KNW 1999-12-27

15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE

Applicant Imagyn Surgical

K number K993936

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KNW 1999-12-23

DUCPREP BREAST ASPIRATOR, MODEL PMPO2

Applicant Windy Hill Technology, Inc.

K number K993342

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KNW 1999-12-06

MANUAL BONE MARROW BIOPSY DEVICE

Applicant Promex, Inc.

K number K993435

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KNW 1999-11-18

11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT

Applicant Ethicon Endo-Surgery, Inc.

K number K992813

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KNW 1999-08-17

MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,

Applicant Ethicon Endo-Surgery, Inc.

K number K991980

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KNW 1999-08-12

GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE

Applicant Gallini U.S., LLC

K number K992499

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KNW 1999-06-25

DAUM MRI/CONVENTIONAL BIOPSY KIT

Applicant Daum GmbH

K number K991366

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KNW 1999-06-09

FUJI CATHETER, MODEL CTH001

Applicant Windy Hill Technology, Inc.

K number K983867

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KNW 1999-06-04

AUTO SUTURE ABBI SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K983296

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KNW 1999-05-20

TRU-CORE I REUSABLE BIOPSY INSTRUMENT

Applicant Medical Device Technologies, Inc.

K number K990839

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KNW 1999-05-19

GALLINI ATRA-CUT NEEDLE

Applicant Gallini U.S., LLC

K number K990645

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KNW 1999-05-17

GALLINI BYCUT NEEDLE

Applicant Gallini U.S., LLC

K number K990716

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KNW 1999-05-13

MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM

Applicant International Medical Systems

K number K990515

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KNW 1999-04-28

DAUM NEUROGATE TROCAR

Applicant Daum GmbH

K number K990782

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