GBM — Catheter, Urethral Class II
FDA Device Classification
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 |