Cleared Special

K123865 - VISUAL-ICE CRYOABLATION SYSTEM

K123865 is the FDA 510(k) clearance for VISUAL-ICE 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 51-day FDA review.

K123865 · Galil Medical, Inc. · General & Plastic Surgery device
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Feb 2013
Decision
51d
Days
Class 2
Risk

K123865 is an FDA 510(k) clearance for the VISUAL-ICE CRYOABLATION SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical, Inc. (Fulshear, US). The FDA issued a Cleared decision on February 6, 2013 after a review of 51 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 K123865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2012
Decision Date February 06, 2013
Days to Decision 51 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
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 81
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K123865.
ERBECRYO 2 Cryosurgical Unit with accessories
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ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
K121507 · AtriCure, Inc. · Jun 2012
ATRICURE CRYO MODULE SYSTEM
K112072 · AtriCure, Inc. · Aug 2011
ATRICURE CRYO MODULE
K111042 · AtriCure, Inc. · May 2011