K132890 is an FDA 510(k) clearance for the SUPRAPUBIC CATHETER AND INTRODUCER SET, a Catheter, Suprapubic (and Accessories) (Class II — Special Controls, product code KOB), submitted by Mediplus , Ltd. (High Wycombe, Bucks, GB). The FDA issued a Cleared decision on January 17, 2014, 123 days after receiving the submission on September 16, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K132890 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 2013 |
| Decision Date | January 17, 2014 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOB — Catheter, Suprapubic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5090 |