Cleared Traditional

K012497 - CRYO-HIT

K012497 is an FDA 510(k) clearance for CRYO-HIT, 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 88-day FDA review.

K012497 · Galil Medical , Ltd. · General & Plastic Surgery device
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Oct 2001
Decision
88d
Days
Class 2
Risk

K012497 is an FDA 510(k) clearance for the CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical , Ltd. (Washington, US). The FDA issued a Cleared decision on October 30, 2001 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Galil Medical , Ltd. devices

FDA 510(k) Submission Details - K012497

510(k) Number K012497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date October 30, 2001
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K012497.
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · Galil Medical , Ltd. · Jul 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · Galil Medical , Ltd. · Jan 2002
CRYOCARE SURGICAL SYSTEM
K011074 · Endocare, Inc. · Jan 2002
CRYOCARE SURGICAL SYSTEM
K003811 · Endocare, Inc. · Oct 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · Galil Medical , Ltd. · May 2001
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · Endocare, Inc. · Nov 2000