Cleared Special

K130599 - WART FREEZE

K130599 is an FDA 510(k) clearance for WART FREEZE, manufactured by Koninklijke Utermohlen NV. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 90-day FDA review.

K130599 · Koninklijke Utermohlen NV · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
90d
Days
Class 2
Risk

K130599 is an FDA 510(k) clearance for the WART FREEZE. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Koninklijke Utermohlen NV (San Diego, US). The FDA issued a Cleared decision on June 5, 2013 after a review of 90 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130599

510(k) Number K130599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date June 05, 2013
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 249
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K130599.
ATRICURE CRYO MODULE SYSTEM
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K131523 · C2 Therapeutics · Aug 2013
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K130995 · Nuance Medical, LLC · Jun 2013
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K123865 · Galil Medical, Inc. · Feb 2013
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
K130599 · WART FREEZE
Download PDF FDA Summary Koninklijke Utermohle…