K152580 is an FDA 510(k) clearance for the rescuenet, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 3, 2015, 54 days after receiving the submission on September 10, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K152580 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2015 |
| Decision Date | November 03, 2015 |
| Days to Decision | 54 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 |