K252056 is an FDA 510(k) clearance for the Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100). This device is classified as a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II - Special Controls, product code OCL).
Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on July 24, 2025, 23 days after receiving the submission on July 1, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 878.4400. Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue.
| 510(k) Number | K252056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2025 |
| Decision Date | July 24, 2025 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OCL — Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |