510(k) K181071 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SIRA RFA Electrosurgical Device
| Applicant | Innoblative Designs, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Jan 16, 2019 |
| Received | Apr 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181071
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.