Cleared Abbreviated

K072651 - CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM

K072651 is an FDA 510(k) clearance for CRYOSPRAY ABLATION SYSTEM, manufactured by CSA Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K072651 · CSA Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
79d
Days
Class 2
Risk

K072651 is an FDA 510(k) clearance for the CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by CSA Medical, Inc. (Baltimore, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 79 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all CSA Medical, Inc. devices

FDA 510(k) Submission Details - K072651

510(k) Number K072651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2007
Decision Date December 07, 2007
Days to Decision 79 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

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 201
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