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

    GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT

    K Number: K864056 · Decision Oct 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    15
    Review Days
    16

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    Basic Information

    Device Name
    GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT
    K Number
    K864056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Grieshaber & Co.
    Date Received
    October 15, 1986
    Decision Date
    October 31, 1986
    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 Grieshaber & Co.

    K Number Device Name
    K950056 THE GRIESHABER AXIAL CUTTER
    K930842 THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
    K914588 GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE
    K914587 GRIESHABER AIR/FLUID TUBING SET
    K914585 GRIESHABER TWO FUNCTION MANIPULATOR
    K914586 GRIESHABER THREE FUNCTION MANIPULATOR
    K897119 GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP
    K900714 ZZIPP INSTANT BOVIE CLEANER
    K890782 GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)
    K890783 GRIESHABER VISCOELASTIC INJECTION SYSTEM
    Search all 15 clearances from Grieshaber & Co. →