BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODEL GT1ST CRYOSURGICAL INSTRUMENT

    K Number: K922878 · Decision Sep 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    3
    Review Days
    79

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    Basic Information

    Device Name
    MODEL GT1ST CRYOSURGICAL INSTRUMENT
    K Number
    K922878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gyne-Tech Instrument Corp.
    Date Received
    June 15, 1992
    Decision Date
    September 2, 1992
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Gyne-Tech Instrument Corp.

    K Number Device Name
    K954911 OMEGA ULTRASCAN
    K914367 ELECTROSURGICAL GENERATOR MODEL ESU100/250/550