KNY · Class II · 21 CFR 876.5130

FDA Product Code KNY: Accessories, Catheter, G-u

Leading manufacturers include Lake Region Mfg., Inc., Promepla Sam and Solace Therapeutics.

65
Total
65
Cleared
105d
Avg days
1976
Since
65 devices
25–48 of 65
Cleared Apr 25, 1995
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488
The Kendal Co.
Gastroenterology & Urology · 25d
Cleared Jan 24, 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835
Orion Life Systems, Inc.
Gastroenterology & Urology · 172d
Cleared Oct 07, 1994
AMPLATZ SUPER STIFF GUIDEWIRE
K944754
Boston Scientific Corp
Gastroenterology & Urology · 11d
Cleared Sep 21, 1994
UROLOGICAL GUIDWIRE
K944135
Applied Medical Resources
Gastroenterology & Urology · 28d
Cleared Sep 08, 1994
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K934072
Contour Fabricators of Florida, Inc.
Gastroenterology & Urology · 384d
Cleared Jul 07, 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Jun 24, 1994
FLEXFINDER GUIDEWIRE
K942074
Flexmedics
Gastroenterology & Urology · 56d
Cleared Jun 10, 1994
SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE
K935643
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 196d
Cleared Dec 01, 1993
FLEXI-TRAK ANCHORING DEVICE
K932143
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 215d
Cleared Jul 21, 1993
NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
K925161
North American Sterilization & Packaging Co.
Gastroenterology & Urology · 281d
Cleared May 27, 1993
URINARY CARE SUPPLIES
K923496
Orion Life Systems, Inc.
Gastroenterology & Urology · 316d
Cleared Mar 05, 1993
HYDROPHILIC COATED GUIDEWIRE
K926344
Surgitek
Gastroenterology & Urology · 78d
Cleared Sep 04, 1992
GUIDEWIRE
K921200
Lake Region Mfg., Inc.
Gastroenterology & Urology · 176d
Cleared May 11, 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 67d
Cleared Dec 13, 1991
MENTOR INFUSION LINE
K912919
Mentor Corp.
Gastroenterology & Urology · 163d
Cleared Nov 29, 1990
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 15d
Cleared Mar 06, 1990
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031
Porges Corp.
Gastroenterology & Urology · 61d
Cleared Feb 26, 1990
CATHETER PLUG/PROTECTOR
K896806
Westmark, Sterile Packing Systems, Inc. (Sps)
Gastroenterology & Urology · 87d
Cleared Jul 12, 1988
TECNOL CATHETER LEG STRAP
K882641
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 15d
Cleared Oct 19, 1983
DEFLECTING GUIDE WIRE
K833242
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 12, 1977
SAFEED DISP. PLASTIC CATHETER
K771212
Terumo America, Inc.
Gastroenterology & Urology · 69d
Cleared Nov 23, 1976
SILASTIC BRAND GASTRIC LAVAGE TUBE
K760943
Dow Corning Corp. Healthcare Industries Materials
Gastroenterology & Urology · 22d