K222279 is an FDA 510(k) clearance for the Rusch Intermittent Urethral Catheters. This device is classified as a Catheter, Coude (Class II - Special Controls, product code EZC).
Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 29, 2022, 31 days after receiving the submission on July 29, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K222279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2022 |
| Decision Date | August 29, 2022 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZC — Catheter, Coude |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |