510(k) K202114 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
| Applicant | Bolder Surgical, LLC, Louisville CO, US |
| Decision | Substantially Equivalent, Oct 6, 2020 |
| Received | Jul 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2022 | Bolder Surgical, LLC CoolSeal Generator, REF: CSL-200-50 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.