510(k) K162810 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
InSeca ARC Stylus, Aerin Console
| Applicant | Aerin Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 11, 2017 |
| Received | Oct 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162810
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.