Visual-ICE Cryoablation System, Software Revision 1.3.1— 510(k) K143564

Clearance details

Applicant

Galil Medical, Inc.

Product code

Code GEH

Device class

Class 2

Regulation

21 CFR 878.4350

Advisory panel

General, Plastic Surgery

Date received

2014-12-16

Decision date

2015-03-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Arden Hills, MN, US

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• K181153 — ICEfx Cryoablation System2018-05-15
• K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel2017-11-21
• K123865 — VISUAL-ICE CRYOABLATION SYSTEM2013-02-06

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 →

• Z-0404-2020 — Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.Class II·Terminated·Galil Medical, Inc.·20191025

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143564.