K183335 is an FDA 510(k) clearance for the Medline Poly-Cath Red Polymer Urethral Catheter. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on June 12, 2019, 191 days after receiving the submission on December 3, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K183335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2018 |
| Decision Date | June 12, 2019 |
| Days to Decision | 191 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 |