GBM · Class II · 21 CFR 876.5130

FDA Product Code GBM: Catheter, Urethral

Leading manufacturers include Hollister Incorporated, Coloplast and Coloplast Corp..

71
Total
71
Cleared
119d
Avg days
1976
Since
71 devices
49–71 of 71
Cleared Mar 13, 1997
PERSONAL CATHETER
K970704
Rochester Medical Corp.
Gastroenterology & Urology · 15d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067
Boston Scientific Corp
Gastroenterology & Urology · 41d
Cleared Oct 31, 1996
ASTA-CATH
K961361
A+ Products
Gastroenterology & Urology · 205d
Cleared May 16, 1994
URI-CATH CATHETER
K941672
Gesco Intl., Inc.
Gastroenterology & Urology · 41d
Cleared May 21, 1993
WALTHER CATHETERS, MALE, FEMALE
K926369
Thomasville Medical Assoc.
Gastroenterology & Urology · 150d
Cleared Mar 20, 1992
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905
American Medical Systems, Inc.
Gastroenterology & Urology · 140d
Cleared May 28, 1991
AUTOCATH(TM) SET
K910876
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 23, 1989
KENDALL CURITY URETHRAL CATHETERS
K892442
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Aug 12, 1988
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH
K881667
The Kendal Co.
Gastroenterology & Urology · 116d
Cleared Apr 06, 1983
OPEN ENDED URETERAL CATHETER
K830840
Van-Tec, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 23, 1976
CATHETER, SILICONE FOLEY (BARDEX)
K760093
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Aug 23, 1976
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
K760253
C.R. Bard, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 23, 1976
TRAY, FOLEY CATHETER
K760254
C.R. Bard, Inc.
Gastroenterology & Urology · 35d