510(k) K213831 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
| Applicant | Gyrus Acmi, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Jan 4, 2022 |
| Received | Dec 8, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213831
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.