The following data is part of a premarket notification filed by Chirurgie Innovation with the FDA for Plasma Edge System.
| Device ID | K163090 |
| 510k Number | K163090 |
| Device Name: | Plasma Edge System |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | Chirurgie Innovation 27 PLACE VICTOR SCHOELCHER Massy, FR F-91300 |
| Contact | Guillaume Noury |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FAS |
| Subsequent Product Code | FDC |
| Subsequent Product Code | GEI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2017-05-23 |
| Summary: | summary |