FDA product code GBM: Catheter, Urethral
GBM is the FDA product code for catheter, urethral. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 71 510(k) submissions under GBM, 3 in the last five years, from 41 different applicants. The average 510(k) review took 119 days (median 90); 261 days on average over the last three years. FDA has posted 18 recalls for GBM devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Urethral |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GBM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 95 |
| 2018 | 6 | 121 |
| 2019 | 7 | 112 |
| 2020 | 6 | 252 |
| 2022 | 2 | 263 |
| 2025 | 1 | 261 |
Compare with all 510(k) review times · Search every GBM clearance
Top GBM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister Incorporated | 10 | 2022-01-27 |
| Coloplast | 6 | 2020-11-13 |
| Coloplast Corp. | 4 | 2016-09-29 |
| B.Braun Medical, Inc. | 3 | 2020-05-07 |
| Coloplast A/S | 3 | 2015-07-02 |
36 more applicants have GBM clearances. See the full list in Caduvo.
Most recent GBM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241734 | Well Lead Medical Co., Ltd. | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | 2025-03-05 | 261 |
| K213283 | Convatec Limited | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | 2022-06-22 | 264 |
| K211436 | Hollister Incorporated | Intermittent Catheter (Not Finalized) | 2022-01-27 | 262 |
| K200820 | Coloplast | SpeediCath Compact Set | 2020-11-13 | 228 |
| K192904 | Coloplast | SpeediCath Compact Set | 2020-11-02 | 384 |
Recalls for GBM devices
18 product recalls in 8 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2026-07-14.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GBM?
GBM is the FDA product code for catheter, urethral. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is GBM?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code GBM?
Across 71 cleared submissions the average was 119 days from receipt to decision (median 90).
Which companies have the most GBM clearances?
Hollister Incorporated (10); Coloplast (6); Coloplast Corp. (4); B.Braun Medical, Inc. (3); Coloplast A/S (3).
Have GBM devices been recalled?
Yes: 18 product recalls across 8 recall events; the most recent began 2026-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code GBM
- Run a recall and safety report across every GBM manufacturer
- Watch product code GBM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times