510(k) K122580 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Nov 9, 2012 |
| Received | Aug 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122580
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.