K101174 is an FDA 510(k) clearance for the ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2. 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. (West Chester, US). The FDA issued a Cleared decision on November 12, 2010, 199 days after receiving the submission on April 27, 2010.
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 | K101174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2010 |
| Decision Date | November 12, 2010 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| 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 |