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

    BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES

    K Number: K062385 · Decision Sep 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    14
    Review Days
    43

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    Basic Information

    Device Name
    BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
    K Number
    K062385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grace Medical, Inc.
    Date Received
    August 15, 2006
    Decision Date
    September 27, 2006
    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
    K061853 GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
    K060518 PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    K991394 STAPES PROSTHESES
    K981575 TYMPANOSTOMY TUBE
    Search all 14 clearances from Grace Medical, Inc. →