Cleared Traditional

K012214 - CRYOPEN AND ACCESSORIES

K012214 is an FDA 510(k) clearance for CRYOPEN AND ACCESSORIES, manufactured by Cimex Biotech, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K012214 · Cimex Biotech, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
284d
Days
Class 2
Risk

K012214 is an FDA 510(k) clearance for the CRYOPEN AND ACCESSORIES. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cimex Biotech, LLC (Covington, US). The FDA issued a Cleared decision on April 26, 2002 after a review of 284 days - an extended review 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: 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.

FDA 510(k) Submission Details - K012214

510(k) Number K012214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date April 26, 2002
Days to Decision 284 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
169d slower than avg
Panel avg: 115d · This submission: 284d
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 261
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K012214.
POLAR WAND
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K021261 · Galil Medical , Ltd. · Jul 2002
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
K021211 · Sanarus Medical, Inc. · Jun 2002
SANARUS VISICA TREATMENT SYSTEM
K020605 · Sanarus Medical, Inc. · Mar 2002
MODIFICATION TO WARTNER WART REMOVAL SYSTEM
K011708 · Wartner Medical Products · Feb 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · Galil Medical , Ltd. · Jan 2002
K012214 · CRYOPEN AND ACCESSORIES
Download PDF FDA Summary Cimex Biotech, LLC