K172924 is an FDA 510(k) clearance for the GentleCath Intermittent Urinary Catheter, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on November 21, 2017, 57 days after receiving the submission on September 25, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K172924 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2017 |
| Decision Date | November 21, 2017 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |