510(k) K193356 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Mar 2, 2020 |
| Received | Dec 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193356
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.