510(k) K252056 · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Jul 24, 2025 |
| Received | Jul 1, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252056
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.