510(k) K191612 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision AEM Monopolar Laparoscopic Instruments and Accessories
| Applicant | Encision Incorporated, Boulder CO, US |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Jun 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191612
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.