K942110 is an FDA 510(k) clearance for the INJECT-SNARE. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Endovations (Reading, US). The FDA issued a Cleared decision on October 13, 1994, 164 days after receiving the submission on May 2, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K942110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1994 |
| Decision Date | October 13, 1994 |
| Days to Decision | 164 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 |