GBM · Class II · 21 CFR 876.5130

FDA Product Code GBM: Catheter, Urethral

Leading manufacturers include Coloplast, Hollister Incorporated and C.R. Bard, Inc..

71
Total
71
Cleared
119d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 261d recently vs 117d historically

FDA 510(k) Cleared Catheter, Urethral Devices (Product Code GBM)

71 devices
1–24 of 71
Cleared Mar 05, 2025
Wellead® Hydrophilic Intermittent Catheter Ready to Use
K241734
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 261d
Cleared Jun 22, 2022
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283
Convatec Limited
Gastroenterology & Urology · 264d
Cleared Jan 27, 2022
Intermittent Catheter (Not Finalized)
K211436
Hollister Incorporated
Gastroenterology & Urology · 262d
Cleared Nov 13, 2020
SpeediCath Compact Set
K200820
Coloplast
Gastroenterology & Urology · 228d
Cleared Nov 02, 2020
SpeediCath Compact Set
K192904
Coloplast
Gastroenterology & Urology · 384d
Cleared Jul 30, 2020
SpeediCath Soft
K200142
Coloplast
Gastroenterology & Urology · 190d
Cleared Jun 01, 2020
Jimushi Sterile Urethral Catheter for single use
K200134
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 132d
Cleared May 21, 2020
LotusCatheter (Lotus No Balloon Catheter)
K191512
Hakki Medical Technologies, Inc.
Gastroenterology & Urology · 349d
Cleared May 07, 2020
Actreen Hi-Lite Intermittent Urinary Catheters
K192577
B.Braun Medical, Inc.
Gastroenterology & Urology · 231d
Cleared Dec 13, 2019
VaPro Plus Pocket, VaPro Plus
K193148
Hollister Incorporated
Gastroenterology & Urology · 30d
Cleared Nov 27, 2019
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter
K192468
Hangzhou Bever Medical Devices Co., Ltd.
Gastroenterology & Urology · 79d
Cleared Jul 19, 2019
Infyna Chic
K191633
Hollister Incorporated
Gastroenterology & Urology · 30d
Cleared Jul 10, 2019
SpeediCath Flex Coude Pro
K190620
Coloplast
Gastroenterology & Urology · 121d
Cleared Jun 12, 2019
Medline Poly-Cath Red Polymer Urethral Catheter
K183335
Medline Industries, Inc.
Gastroenterology & Urology · 191d
Cleared May 08, 2019
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
K183461
Teleflexmedical, Inc.
Gastroenterology & Urology · 145d
Cleared Mar 20, 2019
SimplCath
K182511
F&S Medical Solutions, LLC
Gastroenterology & Urology · 189d
Cleared Dec 18, 2018
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253
Hollister Incorporated
Gastroenterology & Urology · 27d
Cleared Nov 05, 2018
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
K180801
B.Braun Medical, Inc.
Gastroenterology & Urology · 222d
Cleared Oct 25, 2018
SpeediCath Standard
K180258
Coloplast
Gastroenterology & Urology · 268d
Cleared Aug 16, 2018
GentleCath Glide Intermittent Urinary Catheter
K181206
Convatec Limited
Gastroenterology & Urology · 101d
Cleared Jun 22, 2018
VaPro 2 Intermittent Catheter
K180824
Hollister Incorporated
Gastroenterology & Urology · 84d
Cleared Feb 02, 2018
SpeediCath Flex Coude Pro
K180070
Coloplast
Gastroenterology & Urology · 24d
Cleared Nov 22, 2017
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278
Cook Incorporated
Gastroenterology & Urology · 117d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067
Boston Scientific Corp
Gastroenterology & Urology · 41d

About Product Code GBM - Regulatory Context

510(k) Submission Activity

71 total 510(k) submissions under product code GBM since 1976, with 71 receiving FDA clearance (average review time: 119 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GBM Product Code

Recent submissions under GBM have taken an average of 261 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.

GBM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →