K232665 is an FDA 510(k) clearance for the GentleCath Air for Women (CH10). This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Convatec (Flintshire, GB). The FDA issued a Cleared decision on January 25, 2024, 147 days after receiving the submission on August 31, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K232665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2023 |
| Decision Date | January 25, 2024 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD - Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |