The following data is part of a premarket notification filed by Ecential Robotics with the FDA for Surgivisio Device.
| Device ID | K221028 |
| 510k Number | K221028 |
| Device Name: | SURGIVISIO Device |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres, FR 38610 |
| Contact | Sarah Lefevre-Billard |
| Correspondent | Sarah Lefevre-Billard Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres, FR 38610 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701311500445 | K221028 | 000 |
| 03701311501077 | K221028 | 000 |
| 03701311501053 | K221028 | 000 |
| 03701311501039 | K221028 | 000 |
| 03701311501015 | K221028 | 000 |
| 03701311500773 | K221028 | 000 |
| 03701311500766 | K221028 | 000 |
| 03701311500759 | K221028 | 000 |
| 03701311500742 | K221028 | 000 |
| 03701311500735 | K221028 | 000 |
| 03701311500728 | K221028 | 000 |
| 03701311500711 | K221028 | 000 |
| 03701311500285 | K221028 | 000 |
| 03701311500056 | K221028 | 000 |
| 03701311500421 | K221028 | 000 |
| 03701311500414 | K221028 | 000 |
| 03701311500322 | K221028 | 000 |
| 03701311500308 | K221028 | 000 |
| 03701311500247 | K221028 | 000 |
| 03701311500230 | K221028 | 000 |
| 03701311500223 | K221028 | 000 |
| 03701311500216 | K221028 | 000 |
| 03701311500209 | K221028 | 000 |
| 03701311500193 | K221028 | 000 |
| 03701311500070 | K221028 | 000 |
| 03701311500704 | K221028 | 000 |