Cleared Traditional

K172373 - Compound W Nitro-Freeze

K172373 is an FDA 510(k) clearance for Compound W Nitro-Freeze, manufactured by Medtech Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K172373 · Medtech Products, Inc. · General & Plastic Surgery device
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Nov 2017
Decision
87d
Days
Class 2
Risk

K172373 is an FDA 510(k) clearance for the Compound W Nitro-Freeze. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Medtech Products, Inc. (Tarrytown, US). The FDA issued a Cleared decision on November 2, 2017 after a review of 87 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 Medtech Products, Inc. devices

FDA 510(k) Submission Details - K172373

510(k) Number K172373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2017
Decision Date November 02, 2017
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 227
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K172373.
C2 CryoBalloon Ablation System
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CRYOFOS
K170810 · Cryofos Medical GmbH · Sep 2017
truFreeze System
K171626 · CSA Medical, Inc. · Aug 2017
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
K172049 · Cry IQ AB · Aug 2017