AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)— 510(k) K180137

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K180137 for AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF), Substantially Equivalent on 2018-02-15. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2018-01-17
Decision date: 2018-02-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.