510(k) K231872 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
| Applicant | Kirwan Surgical Products, LLC, Marshfield MA, US |
| Decision | Substantially Equivalent, Aug 25, 2023 |
| Received | Jun 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231872
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.