GBM — Catheter, Urethral Class II
FDA product code GBM covers "Catheter, Urethral", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GBM
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241734 | well lead medical co | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic In | March 5, 2025 |
| K213283 | convatec limited | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | June 22, 2022 |
| K211436 | hollister incorporated | Intermittent Catheter (Not Finalized) | January 27, 2022 |
| K200820 | coloplast | SpeediCath Compact Set | November 13, 2020 |
| K192904 | coloplast | SpeediCath Compact Set | November 2, 2020 |
| K200142 | coloplast | SpeediCath Soft | July 30, 2020 |
| K200134 | hangzhou jimushi meditech co | Jimushi Sterile Urethral Catheter for single use | June 1, 2020 |
| K191512 | hakki medical technologies | LotusCatheter (Lotus No Balloon Catheter) | May 21, 2020 |
| K192577 | b.braun medical | Actreen Hi-Lite Intermittent Urinary Catheters | May 7, 2020 |
| K193148 | hollister incorporated | VaPro Plus Pocket, VaPro Plus | December 13, 2019 |
| K192468 | hangzhou bever medical devices co | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to | November 27, 2019 |
| K191633 | hollister incorporated | Infyna Chic | July 19, 2019 |
| K190620 | coloplast | SpeediCath Flex Coude Pro | July 10, 2019 |
| K183335 | medline industries | Medline Poly-Cath Red Polymer Urethral Catheter | June 12, 2019 |
| K183461 | teleflexmedical | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermitt | May 8, 2019 |
| K182511 | f and s medical solutions | SimplCath | March 20, 2019 |
| K183253 | hollister incorporated | ValPro 2 Plus, VaPro 2 Plus Pocket | December 18, 2018 |
| K180801 | b.braun medical | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | November 5, 2018 |
| K180258 | coloplast | SpeediCath Standard | October 25, 2018 |
| K181206 | convatec limited | GentleCath Glide Intermittent Urinary Catheter | August 16, 2018 |