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FDA 510(k)

MODEL GT1ST CRYOSURGICAL INSTRUMENT

K-Number: K922878 · 1992-09-02

ApplicantGyne-Tech Instrument Corp.
Decision Date1992-09-02
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL GT1ST CRYOSURGICAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Gyne-Tech Instrument Corp.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K922878. 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 MODEL GT1ST CRYOSURGICAL INSTRUMENT?

MODEL GT1ST CRYOSURGICAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Gyne-Tech Instrument Corp.. The 510(k) number is K922878.

When did MODEL GT1ST CRYOSURGICAL INSTRUMENT receive FDA 510(k) clearance?

MODEL GT1ST CRYOSURGICAL INSTRUMENT received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922878.

Who is the listed applicant for MODEL GT1ST CRYOSURGICAL INSTRUMENT?

The FDA 510(k) record lists Gyne-Tech Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL GT1ST CRYOSURGICAL INSTRUMENT?

The FDA product code for MODEL GT1ST CRYOSURGICAL INSTRUMENT 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 Gyne-Tech Instrument Corp. 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.

K954911OMEGA ULTRASCANK914367ELECTROSURGICAL GENERATOR MODEL ESU100/250/550

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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