Cleared Traditional

K101825 - CRYOBALLOON ABLATION SYSTEM

K101825 is an FDA 510(k) clearance for CRYOBALLOON ABLATION SYSTEM, manufactured by C2 Therapeutics. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K101825 · C2 Therapeutics · General & Plastic Surgery device
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Sep 2010
Decision
90d
Days
Class 2
Risk

K101825 is an FDA 510(k) clearance for the CRYOBALLOON 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 September 29, 2010 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. 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 C2 Therapeutics devices

FDA 510(k) Submission Details - K101825

510(k) Number K101825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date September 29, 2010
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 218
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K101825.
CRYONIZE TM
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ICESENCE 3
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CRYOMEGA
K102006 · Stc Consulting, LLC · Oct 2010
CRYOCARE CS SURGICAL SYSTEM
K101333 · Endocare, Inc. · Jun 2010
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
K091721 · New Medical Technologies GmbH · Oct 2009
UC-CARE WARMING SYSTEM
K090978 · UC-CARE , Ltd. · Aug 2009