The following data is part of a premarket notification filed by Surgivisio with the FDA for Surgivisio System.
| Device ID | K202547 |
| 510k Number | K202547 |
| Device Name: | Surgivisio System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Surgivisio Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gières, FR 38610 |
| Contact | Vincent Lere |
| Correspondent | Elodie Bouillet Surgivisio Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gières, FR 38610 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-02 |
| Decision Date | 2021-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701311500407 | K202547 | 000 |
| 03701311500032 | K202547 | 000 |
| 03701311500018 | K202547 | 000 |
| 03701311501121 | K202547 | 000 |
| 03701311500995 | K202547 | 000 |
| 03701311500940 | K202547 | 000 |