Cleared Traditional

K011708 - MODIFICATION TO WARTNER WART REMOVAL SYSTEM

K011708 is an FDA 510(k) clearance for MODIFICATION TO 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 261-day FDA review.

K011708 · 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
Feb 2002
Decision
261d
Days
Class 2
Risk

K011708 is an FDA 510(k) clearance for the MODIFICATION TO 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 February 20, 2002 after a review of 261 days - an extended review 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: 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 - K011708

510(k) Number K011708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date February 20, 2002
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
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 261
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K011708.
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CRYOPEN AND ACCESSORIES
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SANARUS VISICA TREATMENT SYSTEM
K020605 · Sanarus Medical, Inc. · Mar 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · Galil Medical , Ltd. · Jan 2002
CRYOCARE SURGICAL SYSTEM
K011074 · Endocare, Inc. · Jan 2002
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · Galil Medical , Ltd. · Oct 2001
K011708 · MODIFICATION TO WARTNER WART REMOVAL SYSTEM
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