Cleared Special

CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (K023757) - FDA 510(k) Clearance

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

K023757 · Endocare, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
27d
Days
Class 2
Risk

K023757 is an FDA 510(k) clearance for the CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20. 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 December 5, 2002 after a review of 27 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 Endocare, Inc. devices

Submission Details

510(k) Number K023757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2002
Decision Date December 05, 2002
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 65
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K023757.
Freezpoint
K180211 · Bovie Medical Corp. · Mar 2018
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
K180137 · AtriCure, Inc. · Feb 2018
C2 CryoBalloon Ablation System
K163684 · C2 Therapeutics, Inc. · Jan 2018
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · Boston Scientific Corp · Jun 1996