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
25–48 of 71
Cleared Sep 29, 2016
SpeediCath Flex Coude
K161672
Coloplast Corp.
Gastroenterology & Urology · 112d
Cleared Jun 16, 2016
United Urologics Intermittent Catheter
K160795
Robling Medical
Gastroenterology & Urology · 85d
Cleared Feb 09, 2016
Actreen Mini Intermittent Urinary Catheters
K151772
B.Braun Medical, Inc.
Gastroenterology & Urology · 224d
Cleared Sep 09, 2015
VAPRO PLUS POCKET Intermittent Catheter
K152268
Hollister Incorporated
Gastroenterology & Urology · 29d
Cleared Jul 02, 2015
SpeediCath Compact Eve
K150935
Coloplast A/S
Gastroenterology & Urology · 86d
Cleared Feb 03, 2015
ThinkMed Intermittent Catheter with/without Hydrophilic Coating
K142767
Thinkmed Medical Technology Co., Ltd.
Gastroenterology & Urology · 131d
Cleared Jan 20, 2015
Speedicath Compact Male
K143182
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Jan 09, 2015
VaPro Pocket
K143594
Hollister Incorporated
Gastroenterology & Urology · 22d
Cleared Aug 22, 2014
VAPRO INTERMITTENT CATHETER
K141642
Hollister Incorporated
Gastroenterology & Urology · 64d
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 Feb 13, 2012
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
K111405
Hangzhou Bever Medical Devices Co., Ltd.
Gastroenterology & Urology · 270d
Cleared Apr 26, 2011
VAPRO PLUS INTERMITTENT CATHETER
K110862
Hollister Incorporated
Gastroenterology & Urology · 28d
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 May 05, 2005
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
K050874
Astra Tech, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 23, 2004
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241
Astra Tech, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 17, 2003
URINARY CATHETERS
K031409
Promedic, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 27, 2003
SPEEDICATH
K023254
Coloplast Corp.
Gastroenterology & Urology · 119d
Cleared Jul 01, 2002
RUSCH FLONEIL
K020714
Rusch Intl.
Gastroenterology & Urology · 118d
Cleared Aug 23, 2001
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374
Astra Tech, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 23, 1999
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651
Sc Hennig Enterprises Europe Srl
Gastroenterology & Urology · 55d
Cleared Sep 03, 1999
UROLOGICAL CATHETER
K992137
Apogee, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 25, 1998
READYCATH CATHETER
K973120
Medical Technologies of Georgia
Gastroenterology & Urology · 189d