The following data is part of a premarket notification filed by Ecential Robotics with the FDA for Surgivisio Device.
| Device ID | K220946 |
| 510k Number | K220946 |
| Device Name: | SURGIVISIO Device |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres, FR 38610 |
| Contact | Mathilde Saulpic |
| Correspondent | Mathilde Saulpic Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres, FR 38610 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-01 |
| Decision Date | 2022-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701311500391 | K220946 | 000 |
| 03701311500971 | K220946 | 000 |