K183289 is an FDA 510(k) clearance for the ClearGrasp Snare. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Finemedix Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on March 6, 2019, 100 days after receiving the submission on November 26, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K183289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2018 |
| Decision Date | March 06, 2019 |
| Days to Decision | 100 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 |