K203637 is an FDA 510(k) clearance for the SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814). This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on March 8, 2022, 449 days after receiving the submission on December 14, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K203637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2020 |
| Decision Date | March 08, 2022 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD - Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |