Cleared Special

K181153 - ICEfx Cryoablation System

K181153 is the FDA 510(k) clearance for ICEfx Cryoablation System by Galil Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Special 510(k) pathway after a 14-day FDA review.

K181153 · Galil Medical, Inc. · General & Plastic Surgery device
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May 2018
Decision
14d
Days
Class 2
Risk

K181153 is an FDA 510(k) clearance for the ICEfx Cryoablation System. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical, Inc. (Arden Hills, US). The FDA issued a Cleared decision on May 15, 2018 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Galil Medical, Inc. devices

Submission Details

510(k) Number K181153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2018
Decision Date May 15, 2018
Days to Decision 14 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 80
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K181153.
ClariFix
K190356 · Arrinex, Inc. · Feb 2019
Frozen C
K182392 · B.M. Tech. Worldwide Co., Ltd. · Oct 2018
IceSphere 1.5 CX Cryoablation Needle
K181741 · Galil Medical , Ltd. · Jul 2018
Freezpoint
K180211 · Bovie Medical Corp. · Mar 2018
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
K180137 · AtriCure, Inc. · Feb 2018
C2 CryoBalloon Ablation System
K163684 · C2 Therapeutics, Inc. · Jan 2018