Cleared Traditional

K955083 - VERRUCA-FREEZE CRYOSURGICAL DELIVERY SY...

K955083 is an FDA 510(k) clearance for VERRUCA-FREEZE CRYOSURGICAL DELIVERY SY..., manufactured by Cryosurgery, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K955083 · Cryosurgery, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
136d
Days
Class 2
Risk

K955083 is an FDA 510(k) clearance for the VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION). Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 136 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 Cryosurgery, Inc. devices

FDA 510(k) Submission Details - K955083

510(k) Number K955083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date February 08, 1996
Days to Decision 136 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 115d · This submission: 136d
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 116
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K955083.
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