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

    SURGIN GENISIS HANDPIECE

    K Number: K954238 · Decision Dec 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    23
    Review Days
    88

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    Basic Information

    Device Name
    SURGIN GENISIS HANDPIECE
    K Number
    K954238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgin Surgical Instrumentation, Inc.
    Date Received
    September 11, 1995
    Decision Date
    December 8, 1995
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Surgin Surgical Instrumentation, Inc.

    K Number Device Name
    K082110 DUAL SYRINGE HOLDER
    K033236 PRIZM KERATOME BLADE, MODEL MK8512M2
    K033182 PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
    K011195 PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
    K994015 ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
    K980849 SURGIN KIT
    K950600 VACUUM SURGE SUPRESSER
    K942945 CASSETTE SYSTEM FOR STORZ
    K942944 IRRIGATION/BIPOLAR SET
    K942897 OPTHALMIC WIPE
    Search all 23 clearances from Surgin Surgical Instrumentation, Inc. →