K121458 is an FDA 510(k) clearance for the SPEEDICATH COMPACT SET (12/18 FR). This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on October 1, 2012, 138 days after receiving the submission on May 16, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K121458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2012 |
| Decision Date | October 01, 2012 |
| Days to Decision | 138 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 |