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FDA 510(k)

Dr. Yglo Wart Remover

K-Number: K210529 · 2021-05-06

ApplicantTheotclab Healthcare B.V.
Decision Date2021-05-06
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dr. Yglo Wart Remover is the device name listed in this FDA 510(k) record. The listed applicant is Theotclab Healthcare B.V.. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K210529. 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 Dr. Yglo Wart Remover?

Dr. Yglo Wart Remover is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Theotclab Healthcare B.V.. The 510(k) number is K210529.

When did Dr. Yglo Wart Remover receive FDA 510(k) clearance?

Dr. Yglo Wart Remover received FDA 510(k) clearance on 2021-05-06, under 510(k) number K210529.

Who is the listed applicant for Dr. Yglo Wart Remover?

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

What is the FDA product code for Dr. Yglo Wart Remover?

The FDA product code for Dr. Yglo Wart Remover is GEH.

Other records listing Theotclab Healthcare 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.

K251524Dr. Yglo 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

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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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