Cleared Traditional

K121251 - ICEROD CX CRYOABLATION NEEDLE ICEROD CX...

K121251 is an FDA 510(k) clearance for ICEROD CX CRYOABLATION NEEDLE ICEROD CX..., manufactured by Galil Medical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K121251 · Galil Medical , Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
125d
Days
Class 2
Risk

K121251 is an FDA 510(k) clearance for the ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical , Ltd. (Lake Jackson, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 125 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Galil Medical , Ltd. devices

FDA 510(k) Submission Details - K121251

510(k) Number K121251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2012
Decision Date August 28, 2012
Days to Decision 125 days
Submission Type Traditional
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
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

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 128
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