K211311

Substantially Equivalent

AtriCure Isolator® Synergy Surgical Ablation System

Applicant: AtriCure, Inc.
Product code: OCL
Advisory panel: General, Plastic Surgery
Date received: 2021-04-30
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

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.