Cleared Special

K222272 - truFreeze Console, PN CC301 (FDA 510(k) Clearance)

Also includes:
Aire PV Passive Venting Catheter, PN CO840703 16 Fr CDT 5 Pack, PN 2000181 20Fr CDT 5 Pack, PN ACCCC3CDT05 Active Venting Spray Kit, 20 Fr CDT, PN 2000177 Active Venting Spray Kit 16 Fr CDT, PN 20000516 Rapid AV Catheter 5 Pack, PN 2000184

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222272 · STERIS Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
20d
Days
Class 2
Risk

K222272 is an FDA 510(k) clearance for the truFreeze Console, PN CC301. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 18, 2022 after a review of 20 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 STERIS Corporation devices

Submission Details

510(k) Number K222272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2022
Decision Date August 18, 2022
Days to Decision 20 days
Submission Type Special
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
94d faster than avg
Panel avg: 114d · This submission: 20d
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 260
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