Cleared Special

K142441 - cryoICE croablation probe

K142441 is an FDA 510(k) clearance for cryoICE croablation probe, manufactured by AtriCure, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 57-day FDA review.

K142441 · AtriCure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
57d
Days
Class 2
Risk

K142441 is an FDA 510(k) clearance for the cryoICE croablation probe. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on October 29, 2014 after a review of 57 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 AtriCure, Inc. devices

FDA 510(k) Submission Details - K142441

510(k) Number K142441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2014
Decision Date October 29, 2014
Days to Decision 57 days
Submission Type Special
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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 211
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K142441.
ERBECRYO 2 Cryosurgical Unit with accessories
K151041 · Erbe USA, Inc. · May 2015
Visual-ICE Cryoablation System, Software Revision 1.3.1
K143564 · Galil Medical, Inc. · Mar 2015
truFreeze System
K143625 · CSA Medical, Inc. · Jan 2015
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
K141485 · Galil Medical , Ltd. · Jul 2014
TRUFREEZE SYSTEM
K133258 · CSA Medical, Inc. · Jun 2014
WARTIE WART REMOVER
K140314 · Yonmedical BV · Jun 2014