Cleared Traditional

K904421 - CMS ONCOPROBE (TM)

K904421 is an FDA 510(k) clearance for CMS ONCOPROBE (TM), manufactured by Cryomedical Sciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K904421 · Cryomedical Sciences, Inc. · General & Plastic Surgery device
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Apr 1991
Decision
193d
Days
Class 2
Risk

K904421 is an FDA 510(k) clearance for the CMS ONCOPROBE (TM). Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryomedical Sciences, Inc. (Bethesda, US). The FDA issued a Cleared decision on April 8, 1991 after a review of 193 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.

View all Cryomedical Sciences, Inc. devices

FDA 510(k) Submission Details - K904421

510(k) Number K904421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1990
Decision Date April 08, 1991
Days to Decision 193 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 115d · This submission: 193d
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 165
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K904421.
HISTOFREEZER
K924114 · Solarcare Technologies Corp,Inc. · Feb 1993
HISTOFREEZER
K911420 · Solarcare Technologies Corp,Inc. · Jun 1991
WALLACH COLD SOAKER
K910491 · Wallach Surgical Devices, Inc. · May 1991
130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
K882568 · Spembly Medical , Ltd. · Sep 1988
WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM
K880416 · Wallach Surgical Devices, Inc. · Sep 1988
SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
K882962 · Spembly Medical , Ltd. · Aug 1988