Cleared Traditional

K964971 - CRYOGEN CRYOSURGICAL SYSTEM

K964971 is an FDA 510(k) clearance for CRYOGEN CRYOSURGICAL SYSTEM, manufactured by Cryogen, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K964971 · Cryogen, Inc. · General & Plastic Surgery device
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Mar 1997
Decision
106d
Days
Class 2
Risk

K964971 is an FDA 510(k) clearance for the CRYOGEN CRYOSURGICAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryogen, Inc. (San Diego, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 106 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 Cryogen, Inc. devices

FDA 510(k) Submission Details - K964971

510(k) Number K964971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date March 28, 1997
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
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 K964971.
CMS CRYOLITE
K970995 · Cryomedical Sciences, Inc. · Jul 1997
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
K970992 · Premier Dental Products Co. · Jun 1997
FRIGIDERM FRIGISPRAY
K971216 · Dermatologic Lab & Supply, Inc. · May 1997
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
K964336 · Cryomedical Sciences, Inc. · Mar 1997
CRYOSIL SILICONE GEL SHEETING
K964047 · Biodermis Corp. · Mar 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · Endocare, Inc. · Feb 1997