Cleared Traditional

K024009 - CRYOPROBE

K024009 is an FDA 510(k) clearance for CRYOPROBE, manufactured by H&O Equipments, Nv/Sa. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K024009 · H&O Equipments, Nv/Sa · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
106d
Days
Class 2
Risk

K024009 is an FDA 510(k) clearance for the CRYOPROBE. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by H&O Equipments, Nv/Sa (Boulder, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 106 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all H&O Equipments, Nv/Sa devices

FDA 510(k) Submission Details - K024009

510(k) Number K024009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date March 20, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 129
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K024009.
CRYOCARE CS SURGICAL SYSTEM
K032333 · Endocare, Inc. · Aug 2003
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
K031117 · Galil Medical , Ltd. · May 2003
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
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · Galil Medical , Ltd. · Jul 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · Galil Medical , Ltd. · Jan 2002