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Advanced Cryo Wart Remover

by Medical Brands Laboratories B.V.

510(k) K242288

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 NumberK242288 Date21 Jan 2025ClearedStatusActive

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  • Withdrawn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, 6 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 Advanced Cryo Wart Remover is a unit, cryosurgical, accessories device classified under FDA product code GEH and regulation number 878.4350. It is a general, plastic surgery device that has been determined to be substantially equivalent to a predicate device through the FDA 510(k) clearance process.

The device was cleared via the traditional 510(k) pathway with K number K242288, received on August 2, 2024, and cleared on January 21, 2025. It is manufactured by Medical Brands Laboratories B.V. located at Weesperstraat 114, Diemen, Netherlands, postal code 1112AP.

Other devices from Medical Brands Laboratories B.V.

Questions

AI-generated answers, 6 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 Advanced Cryo Wart Remover used for?

    The Advanced Cryo Wart Remover is a unit, cryosurgical, accessories device intended for general plastic surgery applications, as indicated by its classification under FDA product code GEH and regulation number 878.4350 for cryosurgical procedures.

  • How is the Advanced Cryo Wart Remover supplied and is it sterile?

    The device data does not specify whether the Advanced Cryo Wart Remover is supplied sterile or non-sterile, or details about its packaging and supply format; only its classification, manufacturer, and clearance information are provided.

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

    The device data does not indicate whether the Advanced Cryo Wart Remover is designed for single-use or reuse; no specifications regarding reusability, reprocessing, or lifecycle are included in the provided information.

  • What sizes or models are available for the Advanced Cryo Wart Remover?

    No specific sizes, models, or reference numbers beyond the device name 'Advanced Cryo Wart Remover' and its K number K242288 are provided in the data; therefore, no size or model variations can be confirmed from this source.

  • What are the storage requirements for the Advanced Cryo Wart Remover?

    The device data does not include any storage conditions, temperature requirements, or environmental specifications for the Advanced Cryo Wart Remover; such details are not present in the provided information.