Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)— 510(k) K252056

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K252056 for Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100), Substantially Equivalent on 2025-07-24. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2025-07-01
Decision date: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.