OCL
- Product code
- OCL
- Device name
- Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 54
FDA classification definition
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252056 | 2025-07-24 | AtriCure, Inc. | Isolator® Synergy EnCompass Clamp and Guide system | |
| K234151 | 2024-08-27 | AtriCure, Inc. | Isolator Synergy EnCapture Ablation System (EMH) |
Official FDA classification page: OCL
Classification and pathway per current FDA publications. Data from openFDA (CC0).