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FDA 510(k)

WARTNER WART REMOVAL SYSTEM

K-Number: K002714 · 2000-11-28

ApplicantWartner Medical Products
Decision Date2000-11-28
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WARTNER WART REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wartner Medical Products. It received FDA 510(k) clearance on 2000-11-28 under 510(k) number K002714. 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 WARTNER WART REMOVAL SYSTEM?

WARTNER WART REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-28. The listed applicant is Wartner Medical Products. The 510(k) number is K002714.

When did WARTNER WART REMOVAL SYSTEM receive FDA 510(k) clearance?

WARTNER WART REMOVAL SYSTEM received FDA 510(k) clearance on 2000-11-28, under 510(k) number K002714.

Who is the listed applicant for WARTNER WART REMOVAL SYSTEM?

The FDA 510(k) record lists Wartner Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WARTNER WART REMOVAL SYSTEM?

The FDA product code for WARTNER WART REMOVAL SYSTEM is GEH.

Related Clinical Trials

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.

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Other records listing Wartner Medical Products 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.

K030838WARTNER PROK011708MODIFICATION TO WARTNER WART REMOVAL SYSTEM

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix 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.

Official Source

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

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