Skip to content

Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)

by Wartner USA B.V.

510(k) K032271

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032271 Date10 Sep 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wartner Wart Removal System, Model 66715 82000, is a cryosurgical device designed for the removal of common and plantar warts. It operates by applying a freezing agent to the affected tissue, inducing localized destruction of the wart through cryotherapy. This method leverages controlled cold temperatures to treat benign skin lesions effectively.

This device is intended for single-use in clinical or home settings and is classified as a Class II medical device under FDA regulations. It is supplied as a cryosurgical accessory and requires proper handling, including storage at appropriate temperatures to maintain efficacy. The system is authorized under an FDA 510(k) clearance with the product code number 52E022, adhering to cryosurgical standards for wart removal procedures.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of warts is the Wartner Wart Removal System designed to treat?

    The Wartner Wart Removal System, Model 66715 82000, is specifically designed for the removal of common warts and plantar warts. It uses cryotherapy to freeze and destroy the affected tissue, making it suitable for benign skin lesions in these areas.

  • Is the Wartner Wart Removal System intended for use in both clinical and home settings?

    Yes, the device is explicitly labeled for single-use in both clinical and home settings. This means it can be used by healthcare professionals in offices or by patients at home, provided proper instructions and precautions are followed.

  • How should the Wartner Wart Removal System be stored to maintain its effectiveness?

    The device requires storage at appropriate temperatures to preserve its efficacy. While the exact storage conditions aren’t detailed in the provided data, cryosurgical accessories like this typically need to be kept in a cool, dry place away from direct sunlight or extreme temperatures until use.

  • Is the Wartner Wart Removal System reusable, or is it meant for single-use only?

    The device is explicitly designed for single-use only. This ensures sterility and safety, as reuse could compromise the integrity of the freezing mechanism and introduce infection risks.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Wartner Wart Removal System received FDA clearance through a Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. The submission was reviewed by the Skin and Soft Tissue Infections (SU) Advisory Committee under the General, Plastic Surgery specialty, with a decision date of September 10, 2003.