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Wartie Advanced Wart Remover

by Youmedical Corp BV

510(k) K151309

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 NumberK151309 Date14 Aug 2015ClearedStatusActive

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  • Withdrawn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)

Full name
Wartie Advanced Wart Remover or other proprietary name
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, 1 Oct 2026

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

The Wartie Advanced Wart Remover is a cryosurgical accessory (product code GEH) designed for the removal of common and plantar warts. It employs cryotherapy, a technique that uses extreme cold to freeze and destroy targeted tissue. This method is intended for use on adults and children aged 12 years and older, as specified in its intended use.

The device is supplied as a single-use accessory and is regulated under FDA 510(k) clearance (K151309). It is classified as Class II with special controls and intended for use in clinical or home settings. The device is not sterile at the time of shipment and must be prepared for use according to manufacturer instructions, adhering to regulatory standards under 21 CFR 878.4350.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Wartie Advanced Wart Remover used for?

    The Wartie Advanced Wart Remover is a cryosurgical accessory designed specifically for the removal of common and plantar warts. It uses cryotherapy—a technique involving extreme cold—to freeze and destroy targeted tissue, providing a non-invasive treatment option for affected areas.

  • Is the Wartie Advanced Wart Remover single-use or reusable?

    The Wartie Advanced Wart Remover is supplied as a single-use accessory. This design ensures patient safety by preventing cross-contamination and maintaining sterility standards for each procedure, as required by regulatory guidelines.

  • Is the device sterile when shipped?

    No, the Wartie Advanced Wart Remover is not sterile at the time of shipment. It must be prepared for use according to the manufacturer’s instructions to ensure proper sterility before application, adhering to regulatory standards outlined in 21 CFR 878.4350.

  • Where can this device be used, and who is it intended for?

    The Wartie Advanced Wart Remover is intended for use in clinical or home settings and is approved for adults and children aged 12 years and older. Its design allows for flexibility in application environments while ensuring safe and effective wart removal.

  • What regulatory pathway does the Wartie Advanced Wart Remover follow?

    The device is regulated under FDA 510(k) clearance (K151309) and classified as Class II with special controls. This pathway ensures it meets stringent safety and performance standards before market authorization, particularly for cryosurgical accessories under product code GEH.