OCL

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-07-24.

NumberDecision dateApplicantDevice nameSummary
K2520562025-07-24AtriCure, Inc.Isolator® Synergy™ EnCompass Clamp and Guide system PDF
K2341512024-08-27AtriCure, Inc.Isolator Synergy EnCapture Ablation System (EMH)PDF

2 summaries are archived here for direct download.

Official FDA classification page: OCL
Classification and pathway per current FDA publications. Data from openFDA (CC0).