KNY · Class II · 21 CFR 876.5130

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

Leading manufacturers include Lake Region Mfg., Inc., Convatec, A Division of E.R. Squibb & Sons and Orion Life Systems, Inc..

64
Total
64
Cleared
104d
Avg days
1976
Since

FDA 510(k) Cleared Accessories, Catheter, G-u Devices (Product Code KNY)

64 devices
1–24 of 64
Cleared Sep 07, 2018
Bi-Flex Evo
K182144
Promepla Sam
Gastroenterology & Urology · 30d
Cleared Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
K991097
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Jun 05, 1998
HYDROPHILIC COATED GUIDEWIRE
K981667
Lake Region Mfg., Inc.
Gastroenterology & Urology · 25d
Cleared Apr 22, 1998
MANAN MANTA CATHETER FIXATION DISK
K981229
Medical Device Technologies, Inc.
Gastroenterology & Urology · 19d
Cleared Oct 10, 1997
INSULATOR WIRE GUIDE
K972977
Cook Urological, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 05, 1996
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
K960866
Lake Region Mfg., Inc.
Gastroenterology & Urology · 32d
Cleared Mar 26, 1996
MANAN MANTA CATHETER FIXATION DISK
K954132
Manan Medical Products, Inc.
Gastroenterology & Urology · 207d
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 Jul 07, 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Dec 01, 1993
FLEXI-TRAK ANCHORING DEVICE
K932143
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 215d
Cleared May 27, 1993
URINARY CARE SUPPLIES
K923496
Orion Life Systems, Inc.
Gastroenterology & Urology · 316d
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 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

About Product Code KNY - Regulatory Context