Cleared Traditional

K872796 - ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS

K872796 is an FDA 510(k) clearance for ADDITIONS TO WSL NITROSPRAY CRYOSURGICA..., manufactured by Tower Mfg. Co., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K872796 · Tower Mfg. Co., Inc. · General & Plastic Surgery device
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Jul 1987
Decision
16d
Days
Class 2
Risk

K872796 is an FDA 510(k) clearance for the ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Tower Mfg. Co., Inc. (San Antonio, US). The FDA issued a Cleared decision on July 23, 1987 after a review of 16 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tower Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K872796

510(k) Number K872796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date July 23, 1987
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 225
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K872796.
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
SPEMBLY MEDICAL 142 CRYO UNIT
K882963 · Spembly Medical , Ltd. · Aug 1988
CRYOPROBES MC-1400-CRYOSURG-CONSOLE
K832385 · Spembly Medical , Ltd. · Sep 1983
CRYOMEDICS 5000 CRYOPROBES
K832140 · Spembly Medical , Ltd. · Aug 1983
CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
K832334 · Spembly Medical , Ltd. · Aug 1983