510(k) K253634 · GEI Electrosurgical, Cutting & Coagulation & Accessories
CoolSeal Generator® (CSL-200-90)
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253634
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.