K123223 is an FDA 510(k) clearance for the EC SINGLE USE, POLYPECTOMY SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Endochoice, Inc. (Chalotte, US). The FDA issued a Cleared decision on January 10, 2013, 87 days after receiving the submission on October 15, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K123223 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 2012 |
| Decision Date | January 10, 2013 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |