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

    TEF/WIRE PISTON

    K Number: K915121 · Decision Dec 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    16
    Review Days
    40

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    Basic Information

    Device Name
    TEF/WIRE PISTON
    K Number
    K915121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    River Medical, Inc.
    Date Received
    November 13, 1991
    Decision Date
    December 23, 1991
    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

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    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

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

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    mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

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    Other Clearances by River Medical, Inc.

    K Number Device Name
    K023174 DISPOSABLE TEMPORARY PACING WIRE
    K944351 SMARTDOSE IV PREFILLED INFUSION CONTAINER
    K944352 SMARTDOSE III INFUSION CONTAINER
    K945298 SMARTFLOW I ADMINISTRATION SET
    K943692 SMART DOSE(TM)
    K932895 RIVER PUMP
    K933335 RIVER VIAL ADAPTER
    K915120 TEF/PLATINUM PISTON
    K913287 H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
    K913285 PTFE PISTON
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