K140441 is an FDA 510(k) clearance for the BI-FLEX URETERAL ACCESS SHEATH, 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 June 17, 2014, 116 days after receiving the submission on February 21, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K140441 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2014 |
| Decision Date | June 17, 2014 |
| 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 |