K140923 is an FDA 510(k) clearance for the TRACTION POLYPECTOMY SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Ovesco Endoscopy AG (Tuebingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on November 18, 2014, 222 days after receiving the submission on April 10, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K140923 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 10, 2014 |
| Decision Date | November 18, 2014 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |