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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 1989-11-01

MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES

Applicant Advance Medical Designs, Inc.

K number K895457

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KNW 1989-09-08

GASTRO ENTEROLOGICAL BIOPTOME

Applicant Symbiosis Corp.

K number K894419

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KNW 1989-09-08

NOETIX, BIOPSY NEEDLE

Applicant Noetix, Inc.

K number K893992

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KNW 1989-08-08

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE

Applicant Amedic USA

K number K892071

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KNW 1989-03-17

ADMS SILENT NEEDLE GUN

Applicant Advanced Diagnostic Medical Systems, Inc.

K number K882746

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KNW 1989-02-27

STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE

Applicant Boston Scientific Corp

K number K885169

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KNW 1989-01-13

SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER

Applicant Siemens Medical Solutions USA, Inc.

K number K884900

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KNW 1989-01-06

BARD(R) ASPIRATION BIOPSY SYSTEM

Applicant C.R. Bard, Inc.

K number K883469

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KNW 1988-12-05

PROSTATIC CORE-CUT NEEDLE

Applicant Euro-Med Intl.

K number K883884

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KNW 1988-09-29

BARD BIOPSY NEEDLE GUIDANCE DEVICE

Applicant C.R. Bard, Inc.

K number K883374

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KNW 1988-05-20

HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT

Applicant N-S Medical Products

K number K881957

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KNW 1988-05-20

NATIONAL-STANDARD NEEDLE HOLDER

Applicant N-S Medical Products

K number K881956

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KNW 1988-03-02

VAN-TEC AUTO BIOPSY NEEDLE

Applicant Van-Tec, Inc.

K number K880098

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KNW 1988-03-02

VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP

Applicant Van-Tec, Inc.

K number K880096

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KNW 1987-12-31

ENTERON LIVER BIOPSY TRAY

Applicant Endovations

K number K874062

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KNW 1987-12-29

CAREY CAPSULE

Applicant Wilson-Cook Medical, Inc.

K number K873996

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KNW 1987-12-07

WILSON-COOK BIOPSY FORCEPS

Applicant Wilson-Cook Medical, Inc.

K number K874314

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KNW 1987-10-20

SECURLINE FRANSEENE NEEDLE

Applicant Precision Dynamics Corp.

K number K873369

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KNW 1987-08-25

MANAN TURNER STYLE NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K873208

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KNW 1987-06-05

BARD BIOPTY BIOPSY SYSTEM

Applicant C.R. Bard, Inc.

K number K871390

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KNW 1987-04-01

SOFT TISSUE BIOPSY NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K870785

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KNW 1987-03-25

PROSTATIC ASPIRATION BIOPSY SET

Applicant Van-Tec, Inc.

K number K870735

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KNW 1987-03-10

TEFLON BIOPSY CATHETER W/TIP ANGLE

Applicant Van-Tec, Inc.

K number K870734

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KNW 1987-01-20

UROCUT BIOPSY NEEDLE

Applicant Meadox Surgimed, Inc.

K number K861267

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KNW 1986-12-03

MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT

Applicant Dlp, Inc.

K number K864329

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KNW 1986-10-07

PUNCH BIOPSY KIT

Applicant Clinipad Corp.

K number K862562

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KNW 1986-09-23

BMRI SOFT TISSUE BIOPSY NEEDLE

Applicant Bio-Medical Resources, Inc.

K number K861959

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KNW 1986-02-10

BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732

Applicant Travenol Laboratories, S.A.

K number K855003

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KNW 1985-11-26

MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM

Applicant Medsurg Industries, Inc.

K number K854297

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KNW 1985-11-26

MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY

Applicant Medsurg Industries, Inc.

K number K854291

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KNW 1985-08-09

RADI-BIOPSY DEVICE

Applicant Radiplast AB

K number K850605

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KNW 1985-06-21

MANAN MADAYAG PTC NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851839

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KNW 1985-06-21

MANAN CHIBA PTC NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851838

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KNW 1985-06-21

MANAN MENGHINI NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851836

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KNW 1985-05-23

53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN

Applicant Artiberia

K number K851798

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KNW 1985-05-17

MANAN GREENE NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851835

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KNW 1985-05-14

MANAN WESTCOTT NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851837

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KNW 1985-05-14

MANAN FRANSEENE NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851831

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KNW 1985-04-22

FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP

Applicant Precision Dynamics Corp.

K number K851364

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KNW 1985-02-26

RENAL BIOPSY TRAY

Applicant Packaging Technologies, Inc.

K number K850438

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KNW 1982-03-01

BONE BIOPSY SET

Applicant The Anspach Effort, Inc.

K number K820293

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KNW 1982-03-01

MADAYAG TYPE NEEDLE

Applicant Ocean Medical Products, Ltd.

K number K813462

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KNW 1981-11-20

HEPAFIX BIOPSY NEEDLE SET

Applicant Burron Medical Products, Inc.

K number K813085

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KNW 1981-06-09

VANCE PROSTATIC ASPIRATION SET

Applicant Vance Products, Inc.

K number K811454

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KNW 1978-08-14

HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM

Applicant Quinton, Inc.

K number K781038

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KNW 1977-01-26

PROSTATE BIOPSY NEEDLE

Applicant Cook, Inc.

K number K770122

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KNW 1976-11-01

VEST RESTRAINT

Applicant Orthopedic Equipment Co., Inc.

K number K760868

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