Cleared Special

K060144 - SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS

K060144 is an FDA 510(k) clearance for SEEDNET/SEEDNETGOLD, manufactured by Galil Medical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 25-day FDA review.

K060144 · Galil Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
25d
Days
Class 2
Risk

K060144 is an FDA 510(k) clearance for the SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS. 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 February 13, 2006 after a review of 25 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.

FDA 510(k) Submission Details - K060144

510(k) Number K060144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2006
Decision Date February 13, 2006
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 239
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K060144.
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
K060390 · Galil Medical , Ltd. · Apr 2006
SPRAYGENIX CRYO ABLATION SYSTEM
K060555 · Crymed Technologies, Inc. · Apr 2006
CRYOCARE CS SURGICAL SYSTEM
K060279 · Endocare, Inc. · Feb 2006
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
K052259 · Schering-Plough Healthcare Products, Inc. · Dec 2005
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
K052530 · Galil Medical , Ltd. · Nov 2005
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
K052861 · Sanarus Medical, Inc. · Nov 2005