Cleared Traditional

K161202 - C2 Cryoballoon Ablation System

K161202 is an FDA 510(k) clearance for C2 Cryoballoon Ablation System, manufactured by C2 Therapeutics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K161202 · C2 Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
252d
Days
Class 2
Risk

K161202 is an FDA 510(k) clearance for the C2 Cryoballoon Ablation System. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by C2 Therapeutics, Inc. (Redwood, Ca, US). The FDA issued a Cleared decision on January 5, 2017 after a review of 252 days - an extended review 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. 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.

FDA 510(k) Submission Details - K161202

510(k) Number K161202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2016
Decision Date January 05, 2017
Days to Decision 252 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
137d slower than avg
Panel avg: 115d · This submission: 252d
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 239
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K161202.
Dermal Cooling System
K171398 · R2 Dermatology ,Inc · Jul 2017
truFreeze System
K163244 · CSA Medical, Inc. · May 2017
ClariFix Device
K162608 · Arrinex, Inc. · Feb 2017
truFreeze System
K162695 · CSA Medical, Inc. · Oct 2016
IcePearl 2.1 CX L, IceForce 2.1 CX L
K162599 · Galil Medical , Ltd. · Oct 2016
R2 Dermal Cooling System
K161480 · R2 Dermatology · Oct 2016