K121457 is an FDA 510(k) clearance for the SPEEDICATH COMPACT SET (12 FR). This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on October 2, 2012, 139 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 | K121457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2012 |
| Decision Date | October 02, 2012 |
| Days to Decision | 139 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 |