K213135 is an FDA 510(k) clearance for the Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge. This device is classified as a Electrode, Electrosurgical, Active, Urological (Class II - Special Controls, product code FAS).
Submitted by Chirurgie Innovation (Verrières Le Buisson, FR). The FDA issued a Cleared decision on March 2, 2022, 156 days after receiving the submission on September 27, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K213135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | March 02, 2022 |
| Days to Decision | 156 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 |