510(k) K150637 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aerin Medical Wand Model FG011
| Applicant | Aerin Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | Mar 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150637
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.