Cleared Special

K070893 - CRYOSPRAY ABLATION SYSTEM

K070893 is the FDA 510(k) clearance for CRYOSPRAY ABLATION SYSTEM by CSA Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Special 510(k) pathway after a 32-day FDA review.

K070893 · CSA Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
32d
Days
Class 2
Risk

K070893 is an FDA 510(k) clearance for the CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500. 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 May 1, 2007 after a review of 32 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 CSA Medical, Inc. devices

Submission Details

510(k) Number K070893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date May 01, 2007
Days to Decision 32 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 Peers - GEH Unit, Cryosurgical, Accessories

All 81
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K070893.
ATRICURE CRYO MODULE SYSTEM
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K051509 · Erbe USA, Inc. · Jul 2005
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
K970992 · Premier Dental Products Co. · Jun 1997
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · Boston Scientific Corp · Jun 1996