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FDA 510(k)

Advanced Cryo Wart Remover

K-Number: K242288 · 2025-01-21

ApplicantMedical Brands Laboratories B.V.
Decision Date2025-01-21
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Advanced Cryo Wart Remover is the device name listed in this FDA 510(k) record. The listed applicant is Medical Brands Laboratories B.V.. It received FDA 510(k) clearance on 2025-01-21 under 510(k) number K242288. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanced Cryo Wart Remover?

Advanced Cryo Wart Remover is a medical device that received FDA 510(k) clearance on 2025-01-21. The listed applicant is Medical Brands Laboratories B.V.. The 510(k) number is K242288.

When did Advanced Cryo Wart Remover receive FDA 510(k) clearance?

Advanced Cryo Wart Remover received FDA 510(k) clearance on 2025-01-21, under 510(k) number K242288.

Who is the listed applicant for Advanced Cryo Wart Remover?

The FDA 510(k) record lists Medical Brands Laboratories B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Cryo Wart Remover?

The FDA product code for Advanced Cryo Wart Remover is GEH.

Other records listing Medical Brands Laboratories B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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