Cleared Traditional

K030838 - WARTNER PRO

K030838 is an FDA 510(k) clearance for WARTNER PRO, manufactured by Wartner Medical Products. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K030838 · Wartner Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
102d
Days
Class 2
Risk

K030838 is an FDA 510(k) clearance for the WARTNER PRO. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Wartner Medical Products (Richmond Hill, Ontario, CA). The FDA issued a Cleared decision on June 27, 2003 after a review of 102 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.

FDA 510(k) Submission Details - K030838

510(k) Number K030838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2003
Decision Date June 27, 2003
Days to Decision 102 days
Submission Type Traditional
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
13d faster than avg
Panel avg: 115d · This submission: 102d
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 259
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K030838.
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
K032271 · Wartner USA B.V. · Sep 2003
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
K031697 · Schering-Plough Healthcare Products, Inc. · Aug 2003
CRYOCARE CS SURGICAL SYSTEM
K032333 · Endocare, Inc. · Aug 2003
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
K031117 · Galil Medical , Ltd. · May 2003
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
K030303 · Cryocath Technologies, Inc. · Apr 2003
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · OraSure Technologies, Inc. · Mar 2003
K030838 · WARTNER PRO
Download PDF FDA Summary Wartner Medical Produ…