Cleared Special

Isolator? Synergy? EnCompass Clamp and Guide system (OLH, OSH, GPM100)

K252056 · AtriCure, Inc. · Cardiovascular

Jul 2025

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K252056 is an FDA 510(k) clearance for the Isolator? Synergy? EnCompass Clamp and Guide system (OLH, OSH, GPM100), 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 July 24, 2025, 23 days after receiving the submission on July 1, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K252056 FDA.gov
FDA Decision	Cleared 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

Device Classification

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