K073288 is an FDA 510(k) clearance for the ETHICON ENDO SURGERY ARTICULATING SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 12, 2008, 204 days after receiving the submission on November 21, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K073288 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2007 |
| Decision Date | June 12, 2008 |
| Days to Decision | 204 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 |