The following data is part of a premarket notification filed by Chirurgie Innovation with the FDA for Plasma Edge Resection And Vaporization Electrodes, Plasma Edge Working Elements, Adaptor Plasma Edge.
| Device ID | K213135 |
| 510k Number | K213135 |
| Device Name: | Plasma Edge Resection And Vaporization Electrodes, Plasma Edge Working Elements, Adaptor Plasma Edge |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | Chirurgie Innovation Z.A. Les Godets, 3 Rue Des Petits Ruisseaux Verriere Le Buisson, FR 91370 |
| Contact | Guillaume Noury |
| Correspondent | Guillaume Noury Chirurgie Innovation Z.A. Les Godets, 3 Rue Des Petits Ruisseaux Verriere Le Buisson, FR 91370 |
| Product Code | FAS |
| Subsequent Product Code | FDC |
| Subsequent Product Code | GEI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665415002420 | K213135 | 000 |
| 03665415002307 | K213135 | 000 |
| 03665415002284 | K213135 | 000 |
| 03665415002260 | K213135 | 000 |
| 03665415002185 | K213135 | 000 |
| 03665415002178 | K213135 | 000 |
| 03665415002161 | K213135 | 000 |
| 03665415002154 | K213135 | 000 |