K213283 is an FDA 510(k) clearance for the GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on June 22, 2022, 264 days after receiving the submission on October 1, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K213283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2021 |
| Decision Date | June 22, 2022 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM - Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |