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
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 Peers - GEH Unit, Cryosurgical, Accessories

All 93
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K032333.
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · AtriCure, Inc. · Mar 2009
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
K060859 · OraSure Technologies, Inc. · Jul 2006
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · Erbe USA, Inc. · Jul 2005
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · OraSure Technologies, Inc. · Mar 2003
HISTOFREEZER DEVICE
K990877 · OraSure Technologies, Inc. · Jun 1999
HISTOFREEZER DEVICE
K982358 · OraSure Technologies, Inc. · Oct 1998