Cleared Traditional

K152337 - cryoFORM cryoICE cryoablation probe

K152337 is the FDA 510(k) clearance for cryoFORM cryoICE cryoablation probe by AtriCure, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K152337 · AtriCure, Inc. · General & Plastic Surgery device
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Mar 2016
Decision
216d
Days
Class 2
Risk

K152337 is an FDA 510(k) clearance for the cryoFORM cryoICE cryoablation 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 March 22, 2016 after a review of 216 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.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K152337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2015
Decision Date March 22, 2016
Days to Decision 216 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 80
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K152337.
Freezpoint
K180211 · Bovie Medical Corp. · Mar 2018
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
K180137 · AtriCure, Inc. · Feb 2018
C2 CryoBalloon Ablation System
K163684 · C2 Therapeutics, Inc. · Jan 2018
ERBECRYO 2 Cryosurgical Unit with accessories
K151041 · Erbe USA, Inc. · May 2015
cryoICE croablation probe
K142441 · AtriCure, Inc. · Oct 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · AtriCure, Inc. · Jan 2014

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.