K211032 is an FDA 510(k) clearance for the Urinary Catheter 12 Fr, Urinary Catheter 16 Fr. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Urogen Pharma, Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on November 19, 2021, 226 days after receiving the submission on April 7, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K211032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2021 |
| Decision Date | November 19, 2021 |
| Days to Decision | 226 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 |