K220846 is an FDA 510(k) clearance for the CORE-SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on November 21, 2022, 243 days after receiving the submission on March 23, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K220846 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 23, 2022 |
| Decision Date | November 21, 2022 |
| Days to Decision | 243 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 |