510(k) K211579 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
| Applicant | Bolder Surgical, LLC, Louisville CO, US |
| Decision | Substantially Equivalent, Sep 7, 2021 |
| Received | May 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211579
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.