K161600 is an FDA 510(k) clearance for the Resection Electrodes. This device is classified as a Electrode, Electrosurgical (Class II - Special Controls, product code JOS).
Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 6, 2016, 89 days after receiving the submission on June 9, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K161600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2016 |
| Decision Date | September 06, 2016 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JOS — Electrode, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |