IceEdge 2.4 Cryoablation Needle

• • Completed Z-0677-2021 FDA Class II ·initiated 18 Nov 2020

  Complaint trend regarding needle shaft gas leaks.

Full name

Iceedge 2.4 Cryoablation Needle, Iceedge 2.4 Cryoablation Needle Multipack

510(k) Number

K111859 ↗

FDA Product Code

GEH

FDA applicant

Galil Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Galil Medical Ltd →

• What is the IceEdge 2.4 Cryoablation Needle used for?

  The IceEdge 2.4 Cryoablation Needle is used during surgical procedures to destroy tissue by applying extremely cold temperatures when used with a Galil Medical Cryoablation System. It functions as a conduit for high-pressure gas, converting it into extreme cold for freezing or warm for thawing tissue.

• Is the IceEdge 2.4 Cryoablation Needle reusable or single-use?

  The IceEdge 2.4 Cryoablation Needle is supplied as a single-use device and should not be reused. It is designed to be sterile and disposable to ensure patient safety and maintain device integrity during cryoablation procedures.

• What is the regulatory status of the IceEdge 2.4 Cryoablation Needle?

  The IceEdge 2.4 Cryoablation Needle is authorized under FDA 510K clearance, which means it has been determined to be substantially equivalent to predicate devices already on the market for its intended use in cryoablation procedures.

• How is the IceEdge 2.4 Cryoablation Needle supplied?

  The IceEdge 2.4 Cryoablation Needle is supplied as a sterile, single-use disposable component. It is designed to be used with Galil Medical Cryoablation Systems and is available in multipacks for convenience in clinical settings.