Cleared Traditional

K113021 - TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT

K113021 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 Traditional 510(k) pathway after a 119-day FDA review.

K113021 · CSA Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
119d
Days
Class 2
Risk

K113021 is an FDA 510(k) clearance for the TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by CSA Medical, Inc. (Lutherville, US). The FDA issued a Cleared decision on February 7, 2012 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 CSA Medical, Inc. devices

FDA 510(k) Submission Details - K113021

510(k) Number K113021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date February 07, 2012
Days to Decision 119 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
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 200
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K113021.
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
K121251 · Galil Medical , Ltd. · Aug 2012
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
K121507 · AtriCure, Inc. · Jun 2012
VISUAL-ICE CRYOABLATION SYSTEM
K113860 · Galil Medical, Inc. · Mar 2012
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
K111859 · Galil Medical, Inc. · Oct 2011
CRYOPEN CRYOSURGICAL SYSTEM, K102214
K110754 · Cryopen, Inc. · Sep 2011
ATRICURE CRYO MODULE SYSTEM
K112072 · AtriCure, Inc. · Aug 2011