Cleared Traditional

K844246 - NETHERY EXTREMITY FREEZING UNIT

K844246 is an FDA 510(k) clearance for NETHERY EXTREMITY FREEZING UNIT, manufactured by Howard J. Nethery & Assoc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K844246 · Howard J. Nethery & Assoc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
119d
Days
Class 2
Risk

K844246 is an FDA 510(k) clearance for the NETHERY EXTREMITY FREEZING UNIT. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Howard J. Nethery & Assoc. (Louisville, US). The FDA issued a Cleared decision on February 28, 1985 after a review of 119 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 Howard J. Nethery & Assoc. devices

FDA 510(k) Submission Details - K844246

510(k) Number K844246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1984
Decision Date February 28, 1985
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 228
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K844246.
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