The following data is part of a premarket notification filed by Bien-air Surgery Sa with the FDA for Origo System.
| Device ID | K221184 |
| 510k Number | K221184 |
| Device Name: | ORiGO System |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Bien-Air Surgery SA Rue De L'Ouest 2b Le Noirmont, CH 2340 |
| Contact | Jonas Guerdat |
| Correspondent | Yulia Nikova Ken Block Consulting, LLC 800 E. Campbell Rd. Suite 202 Richardson, TX 75081 |
| Product Code | ERL |
| Subsequent Product Code | EQJ |
| Subsequent Product Code | NLY |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-11-02 |