510(k) K212650 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Celeris, Disposable Sinus Debrider
| Applicant | Gyrus Acmi, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Jan 19, 2022 |
| Received | Aug 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212650
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.