GBM · Class II · 21 CFR 876.5130

FDA Product Code GBM: Catheter, Urethral

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

71
Total
71
Cleared
119d
Avg days
1976
Since
71 devices
25–48 of 71
Cleared Feb 09, 2016
Actreen Mini Intermittent Urinary Catheters
K151772
B.Braun Medical, Inc.
Gastroenterology & Urology · 224d
Cleared Jul 02, 2015
SpeediCath Compact Eve
K150935
Coloplast A/S
Gastroenterology & Urology · 86d
Cleared Jan 20, 2015
Speedicath Compact Male
K143182
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Oct 02, 2012
SPEEDICATH COMPACT SET (12 FR)
K121457
Coloplast Corp.
Gastroenterology & Urology · 139d
Cleared Oct 01, 2012
SPEEDICATH COMPACT SET (12/18 FR)
K121458
Coloplast A/S
Gastroenterology & Urology · 138d
Cleared Aug 20, 2009
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960
Hollister, Inc.
Gastroenterology & Urology · 136d
Cleared Nov 09, 2007
SPEEDICATH COMPACT
K072808
Coloplast Corp.
Gastroenterology & Urology · 39d
Cleared Jan 27, 2003
SPEEDICATH
K023254
Coloplast Corp.
Gastroenterology & Urology · 119d
Cleared Jul 01, 2002
RUSCH FLONEIL
K020714
Rusch Intl.
Gastroenterology & Urology · 118d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067
Boston Scientific Corp
Gastroenterology & Urology · 41d
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