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

    CAUSSE MODIFIED TEFLON PISTON, OTOLOGY

    K Number: K760437 · Decision Oct 5, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    48
    Review Days
    50

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    Basic Information

    Device Name
    CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
    K Number
    K760437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    August 16, 1976
    Decision Date
    October 5, 1976
    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)

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

    mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

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

    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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    NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS

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    FDA Class 2 ·Ear, Nose, Throat
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    K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
    K830154 COLLES FRACTURE FRAME
    K823725 SPECTRON PROTRUSIO CUP
    Search all 48 clearances from Richard'S Medical Equip., Inc. →