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

    TYMPANOSTOMY TUBE

    K Number: K981575 · Decision Jul 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    14
    Review Days
    72

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    Basic Information

    Device Name
    TYMPANOSTOMY TUBE
    K Number
    K981575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Grace Medical, Inc.
    Date Received
    May 4, 1998
    Decision Date
    July 15, 1998
    Product Code
    ETD
    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
    ETD Tube, Tympanostomy

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    Other Clearances by Grace Medical, Inc.

    K Number Device Name
    K232059 Tympanostomy Tubes
    K161376 DragonFly Surgical Drill System
    K091187 GRACE DYNAMIC TORP
    K080070 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    K063374 NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
    K062672 GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
    K062385 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
    K061853 GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
    K060518 PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    K991394 STAPES PROSTHESES
    Search all 14 clearances from Grace Medical, Inc. →