510(k) K200318 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Oct 22, 2020 |
| Received | Feb 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200318
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.