K183461 is an FDA 510(k) clearance for the Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 8, 2019, 145 days after receiving the submission on December 14, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K183461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 14, 2018 |
| Decision Date | May 08, 2019 |
| Days to Decision | 145 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 |