Cleared Traditional

K032333 - CRYOCARE CS SURGICAL SYSTEM

K032333 is an FDA 510(k) clearance for CRYOCARE CS SURGICAL SYSTEM, manufactured by Endocare, Inc.. The device is a Class 2 Radiology device with product code GEH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K032333 · Endocare, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
14d
Days
Class 2
Risk

K032333 is an FDA 510(k) clearance for the CRYOCARE CS SURGICAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Endocare, Inc. (Irvin, US). The FDA issued a Cleared decision on August 12, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4350 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endocare, Inc. devices

FDA 510(k) Submission Details - K032333

510(k) Number K032333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2003
Decision Date August 12, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 Radiology devices follow this clearance model.

Regulatory Consultant

Tuv America, Inc.
LAURA DANIELSON

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 218
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K032333.
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
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SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
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HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · OraSure Technologies, Inc. · Mar 2003
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
K023757 · Endocare, Inc. · Dec 2002