Cleared Special

K131523 - CRYOBALLOON FOCAL ABLATION SYSTEM

K131523 is an FDA 510(k) clearance for CRYOBALLOON FOCAL ABLATION SYSTEM, manufactured by C2 Therapeutics. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 86-day FDA review.

K131523 · C2 Therapeutics · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Aug 2013
Decision
86d
Days
Class 2
Risk

K131523 is an FDA 510(k) clearance for the CRYOBALLOON FOCAL ABLATION SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by C2 Therapeutics (Redwood, Ca, US). The FDA issued a Cleared decision on August 22, 2013 after a review of 86 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 C2 Therapeutics devices

FDA 510(k) Submission Details - K131523

510(k) Number K131523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date August 22, 2013
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 93
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K131523.
ERBECRYO 2 Cryosurgical Unit with accessories
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cryoICE croablation probe
K142441 · AtriCure, Inc. · Oct 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · AtriCure, Inc. · Jan 2014
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
K121507 · AtriCure, Inc. · Jun 2012
ATRICURE CRYO MODULE SYSTEM
K112072 · AtriCure, Inc. · Aug 2011
ATRICURE CRYO MODULE
K111042 · AtriCure, Inc. · May 2011