510(k) K221358 · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Dec 30, 2022 |
| Received | May 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221358
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.