510(k) K221184 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
ORiGO System
| Applicant | Bien-Air Surgery SA, Le Noirmont, CH |
| Decision | Substantially Equivalent, Nov 2, 2022 |
| Received | Apr 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221184
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.