Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel— 510(k) K173037

Substantially Equivalent

Galil Medical, Inc.

FDA 510(k) clearance K173037 for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel, Substantially Equivalent on 2017-11-21. Applicant: Galil Medical, Inc..

Clearance details

Applicant: Galil Medical, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2017-09-28
Decision date: 2017-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, 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.