510(k) K161038 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PK Morcellator
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Oct 7, 2016 |
| Received | Apr 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161038
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.