K120160 is an FDA 510(k) clearance for the ROCAMED ROCAUS PLATINUM, a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY), submitted by Promepla Sam (Monaco, MC). The FDA issued a Cleared decision on May 14, 2012, 116 days after receiving the submission on January 19, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K120160 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 19, 2012 |
| Decision Date | May 14, 2012 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |