K102781 is an FDA 510(k) clearance for the RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS. This device is classified as a Electrode, Electrosurgical, Active, Urological (Class II - Special Controls, product code FAS).
Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on January 11, 2011, 106 days after receiving the submission on September 27, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K102781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2010 |
| Decision Date | January 11, 2011 |
| Days to Decision | 106 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAS — Electrode, Electrosurgical, Active, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |