Cleared Special

K140058 - ATRICURE CRYO MODULE SYSTEM

K140058 is an FDA 510(k) clearance for ATRICURE CRYO MODULE SYSTEM, manufactured by AtriCure, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 14-day FDA review.

K140058 · AtriCure, Inc. · General & Plastic Surgery device
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Jan 2014
Decision
14d
Days
Class 2
Risk

K140058 is an FDA 510(k) clearance for the ATRICURE CRYO MODULE SYSTEM. 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 January 24, 2014 after a review of 14 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 AtriCure, Inc. devices

FDA 510(k) Submission Details - K140058

510(k) Number K140058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2014
Decision Date January 24, 2014
Days to Decision 14 days
Submission Type Special
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 faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 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 211
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FDA 510(k) Resources - General & Plastic Surgery

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