Cleared Traditional

K982280 - CRYOPRO MAXI AND CRYOPRO MINI

K982280 is an FDA 510(k) clearance for CRYOPRO MAXI AND CRYOPRO MINI, manufactured by Cortex Technology Aps. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K982280 · Cortex Technology Aps · General & Plastic Surgery device
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Nov 1998
Decision
148d
Days
Class 2
Risk

K982280 is an FDA 510(k) clearance for the CRYOPRO MAXI AND CRYOPRO MINI. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cortex Technology Aps (Washington, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 148 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 Cortex Technology Aps devices

FDA 510(k) Submission Details - K982280

510(k) Number K982280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1998
Decision Date November 25, 1998
Days to Decision 148 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
33d slower than avg
Panel avg: 115d · This submission: 148d
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 164
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K982280.
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VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
K982506 · Cryosurgery, Inc. · Jan 1999
HISTOFREEZER DEVICE
K982358 · OraSure Technologies, Inc. · Oct 1998
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
K982055 · Cryomedical Sciences, Inc. · Sep 1998
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
K980668 · Cryomedical Sciences, Inc. · Jul 1998