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FDA 510(k)

Accurett

K-Number: K161615 · 2016-08-23

ApplicantH&O Equipments, Nv/Sa
Decision Date2016-08-23
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Accurett is the device name listed in this FDA 510(k) record. The listed applicant is H&O Equipments, Nv/Sa. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K161615. 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 Accurett?

Accurett is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is H&O Equipments, Nv/Sa. The 510(k) number is K161615.

When did Accurett receive FDA 510(k) clearance?

Accurett received FDA 510(k) clearance on 2016-08-23, under 510(k) number K161615.

Who is the listed applicant for Accurett?

The FDA 510(k) record lists H&O Equipments, Nv/Sa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accurett?

The FDA product code for Accurett 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 H&O Equipments, Nv/Sa 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.

K024009CRYOPROBE

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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