Accessories, Catheter, G-U

FDA product code KNY · 62 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5130
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-23 – 2026-08-05

KNY 2026-08-05

Transurethral Catheter Safety Valve (TUCSV) (80050)

Applicant Class Medical , Ltd.

K number K260919

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KNY 2018-09-07

Bi-Flex Evo

Applicant Promepla Sam

K number K182144

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KNY 2017-03-02

Vesair Cystoscopic Sheath

Applicant Solace Therapeutics

K number K162356

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KNY 2013-08-20

GUARDIAN URETHRAL SHEATH

Applicant Solace Therapeutics

K number K131803

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KNY 2013-02-04

VARI-PASS VARIABLE LENGTH ACCESS SHEATH

Applicant Olympus Surgical Technologies America

K number K123170

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KNY 2012-05-14

ROCAMED ROCAUS PLATINUM

Applicant Promepla Sam

K number K120160

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KNY 2011-09-08

PREFILLED CATHETER INFLATION SYRINGE

Applicant Avail Medical Products, Inc.

K number K112209

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KNY 2009-04-15

PRE-FILLED CATHETER INFLATION SYRINGE

Applicant Avail Medical Products, Inc.

K number K090121

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KNY 2006-12-12

CYSTOGLIDE INTRODUCER SHEATH

Applicant Percutaneous Systems, Incorporated

K number K052298

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KNY 2006-10-16

CAREVENT

Applicant Chief Medical, LLC

K number K062240

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KNY 2006-05-14

CATHASSIST

Applicant Physician Technologies, Inc.

K number K052952

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KNY 2005-09-22

CYSTOGLIDE DILATING INTRODUCER SHEATH

Applicant Percutaneous Systems, Inc.

K number K052134

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KNY 2005-09-02

UROPASS URETERAL ACCESS SHEATH, MODEL 61224

Applicant Acmi Corporation

K number K051593

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KNY 2005-02-01

UPDATED SLIP UROLOGY INTRODUCER SHEATH

Applicant Percutaneous Systems, Incorporated

K number K042531

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KNY 2004-11-16

MICROVERTER URETERAL ACCESS SHEATH

Applicant Percutaneous Systems, Inc.

K number K042877

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KNY 2004-05-20

SLIP UROLOGY INTRODUCER SHEATH

Applicant Percutaneous Systems, Inc.

K number K040520

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KNY 2003-12-30

HEMEDEX FIXATION DEVICE

Applicant Hemedex Incorporated

K number K032127

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KNY 2003-02-28

CATHETER CONNECTOR

Applicant World Metals, Inc.

K number K023690

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KNY 2000-06-05

MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201

Applicant Memcath Technologies, LLC

K number K000767

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KNY 1999-04-23

PBN DRAINAGE CATHETER GUIDEWIRES

Applicant Medical Device Technologies, Inc.

K number K991097

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KNY 1998-07-30

SNAP-N-PEEL INTRODUCERS

Applicant Circon Corp.

K number K981611

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KNY 1998-06-05

HYDROPHILIC COATED GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K981667

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KNY 1998-04-22

MANAN MANTA CATHETER FIXATION DISK

Applicant Medical Device Technologies, Inc.

K number K981229

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KNY 1997-10-10

INSULATOR WIRE GUIDE

Applicant Cook Urological, Inc.

K number K972977

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KNY 1996-04-05

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

Applicant Lake Region Mfg., Inc.

K number K960866

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KNY 1996-03-26

MANAN MANTA CATHETER FIXATION DISK

Applicant Manan Medical Products, Inc.

K number K954132

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KNY 1995-06-23

PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER

Applicant Acacia Laboratories, Inc.

K number K952414

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KNY 1995-05-24

KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR

Applicant Karl Storz Endoskop GmbH

K number K951995

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KNY 1995-04-25

KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP

Applicant The Kendal Co.

K number K951488

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KNY 1995-01-24

PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID

Applicant Orion Life Systems, Inc.

K number K943835

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KNY 1994-10-07

AMPLATZ SUPER STIFF GUIDEWIRE

Applicant Boston Scientific Corp

K number K944754

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KNY 1994-09-21

UROLOGICAL GUIDWIRE

Applicant Applied Medical Resources

K number K944135

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KNY 1994-09-08

CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM

Applicant Contour Fabricators of Florida, Inc.

K number K934072

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KNY 1994-07-07

ZEBRA UROLOGICAL GUIDEWIRE

Applicant Boston Scientific Corp

K number K942205

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KNY 1994-06-24

FLEXFINDER GUIDEWIRE

Applicant Flexmedics

K number K942074

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KNY 1994-06-10

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE

Applicant Regulatory & Marketing Services, Inc.

K number K935643

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KNY 1993-12-01

FLEXI-TRAK ANCHORING DEVICE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K932143

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KNY 1993-08-09

FOLEY CATHETER TRAY

Applicant Kit Pak, Inc.

K number K931013

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KNY 1993-08-05

GUIDE-TECH ENCAPSULATED GUIDEWIRE

Applicant Cape Tech Medical Products

K number K926039

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KNY 1993-07-21

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

Applicant North American Sterilization & Packaging Co.

K number K925161

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KNY 1993-05-27

URINARY CARE SUPPLIES

Applicant Orion Life Systems, Inc.

K number K923496

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KNY 1993-04-19

KIT PAK URINARY CARE SUPPLIES

Applicant Kit Pak, Inc.

K number K925281

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KNY 1993-03-05

HYDROPHILIC COATED GUIDEWIRE

Applicant Surgitek

K number K926344

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KNY 1992-09-04

GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K921200

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KNY 1992-05-11

KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K921055

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KNY 1991-12-13

MENTOR INFUSION LINE

Applicant Mentor Corp.

K number K912919

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KNY 1991-11-22

CATH CONTROL

Applicant Highpoint Medical Corp.

K number K914211

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KNY 1991-09-05

UNIVERSAL SWIVEL PATCH

Applicant Bryman Medical

K number K913679

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KNY 1991-07-26

URETERAL CATHETER HOLDER

Applicant Inman Liebelt Corp.

K number K912146

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KNY 1990-11-29

FLEXI-TRAK(TM) ANCHORING DEVICE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K905128

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KNY 1990-03-06

MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS

Applicant Porges Corp.

K number K900031

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KNY 1990-02-26

CATHETER PLUG/PROTECTOR

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K896806

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KNY 1989-06-12

PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE

Applicant Medireach, Inc.

K number K890072

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KNY 1989-02-17

O'NEIL URINARY CATHETER INTRODUCER

Applicant Medical Marketing Group

K number K884819

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KNY 1988-07-28

CATHETER WITHDRAWAL UNIT

Applicant Eris Medical Technology

K number K881878

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KNY 1988-07-12

TECNOL CATHETER LEG STRAP

Applicant Tecnol New Jersey Wound Care, Inc.

K number K882641

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KNY 1987-11-27

CLOSED FOLEY CATHETER SYSTEM

Applicant Todd Medical, Inc.

K number K873288

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KNY 1983-10-19

DEFLECTING GUIDE WIRE

Applicant Van-Tec, Inc.

K number K833242

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KNY 1982-05-21

TRANSENDOSCOPIC INJECTION CATHETER TEI

Applicant Sounson Research Co., Inc.

K number K821336

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KNY 1978-12-04

URINARY DRAINAGE BAG

Applicant Kelsar Corp.

K number K781987

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KNY 1977-09-12

SAFEED DISP. PLASTIC CATHETER

Applicant Terumo America, Inc.

K number K771212

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KNY 1976-11-23

SILASTIC BRAND GASTRIC LAVAGE TUBE

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K760943

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