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

    POLY/PLATINUM WIRE PISTON

    K Number: K945105 · Decision May 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    14
    Review Days
    574

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    Basic Information

    Device Name
    POLY/PLATINUM WIRE PISTON
    K Number
    K945105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micromed Development Corp.
    Date Received
    October 18, 1994
    Decision Date
    May 14, 1996
    Product Code
    ETB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETB Prosthesis, Partial Ossicular Replacement

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ETB), ordered by most recent decision date.

    mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)

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    FDA Class 2 ·Ear, Nose, Throat

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    FDA 510(k)
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    mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

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    NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS

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    Other Clearances by Micromed Development Corp.

    K Number Device Name
    K945831 DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT
    K945242 NERVE MONITOR ELECTRODES/STIMULATOR PROBES
    K945104 MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
    K945107 POLY-WIRE PISTON
    K945108 POLY PISTON
    K945106 MICROMED TOTAL REGULAR AND PARTIAL OFFSET
    K945438 EDI-BUR MICRODRILL SYSTEMS
    K943848 COLLAR BUTTON VENTURI VENT TUBE
    K943847 BOBBIN STYLE VENTURI VENT TUBE
    K943849 GROMMENT STYLE VENTURI TUBE
    Search all 14 clearances from Micromed Development Corp. →