K182144 is an FDA 510(k) clearance for the Bi-Flex Evo, 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 September 7, 2018, 30 days after receiving the submission on August 8, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K182144 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 08, 2018 |
| Decision Date | September 07, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |