ICEfx Cryoablation System (FPRCH8000-02)— 510(k) K234002

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K234002 for ICEfx Cryoablation System (FPRCH8000-02), Substantially Equivalent on 2024-03-13. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2023-12-19
Decision date: 2024-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, 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.