K172734 is an FDA 510(k) clearance for the Single Use Electrosurgical Snare SD-400. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on December 7, 2017, 87 days after receiving the submission on September 11, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K172734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2017 |
| Decision Date | December 07, 2017 |
| Days to Decision | 87 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 |