Cleared Special

K162695 - truFreeze System

K162695 is an FDA 510(k) clearance for truFreeze System, manufactured by CSA Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 28-day FDA review.

K162695 · CSA Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Oct 2016
Decision
28d
Days
Class 2
Risk

K162695 is an FDA 510(k) clearance for the truFreeze System. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by CSA Medical, Inc. (Lexington, US). The FDA issued a Cleared decision on October 25, 2016 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all CSA Medical, Inc. devices

FDA 510(k) Submission Details - K162695

510(k) Number K162695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2016
Decision Date October 25, 2016
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 200
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K162695.
truFreeze System
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