Cleared Traditional

K002714 - WARTNER WART REMOVAL SYSTEM

K002714 is an FDA 510(k) clearance for WARTNER WART REMOVAL SYSTEM, 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 89-day FDA review.

K002714 · Wartner Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
89d
Days
Class 2
Risk

K002714 is an FDA 510(k) clearance for the WARTNER WART REMOVAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Wartner Medical Products (Brampton, Ontario, CA). The FDA issued a Cleared decision on November 28, 2000 after a review of 89 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. 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 Wartner Medical Products devices

FDA 510(k) Submission Details - K002714

510(k) Number K002714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2000
Decision Date November 28, 2000
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 178
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K002714.
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · Galil Medical , Ltd. · Oct 2001
CRYOCARE SURGICAL SYSTEM
K003811 · Endocare, Inc. · Oct 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · Galil Medical , Ltd. · May 2001
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · Endocare, Inc. · Nov 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · Galil Medical , Ltd. · Oct 2000
CRYO-HIT
K993965 · Galil Medical , Ltd. · Feb 2000