510(k) K150969 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
| Applicant | Karl Storz Endoscopy America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Jan 8, 2016 |
| Received | Apr 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150969
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.