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

    POREX(TM) EAR PROSTHESIS

    K Number: K863939 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    15
    Review Days
    14

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    Basic Information

    Device Name
    POREX(TM) EAR PROSTHESIS
    K Number
    K863939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3590
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Porex Medical
    Date Received
    October 10, 1986
    Decision Date
    October 24, 1986
    Product Code
    FZD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZD Prosthesis, Ear, Internal

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    Other Clearances by Porex Medical

    K Number Device Name
    K872791 POREX NERVE LOCATOR
    K873044 POREX OTOLOGY INSTRUMENTS
    K872947 POREX QUALITY PLASTIC SURGERY INSTRUMENTS
    K863943 POREX(TM) EYE SPHERE IMPLANT
    K863946 POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
    K870154 POREX(TM) TISSUE EXPANDER
    K870182 POREX(TM) MALAR IMPLANT
    K870257 POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
    K863942 POREX(TM) NOSE PROSTHESIS
    K863941 POREX(TM) PROSTHESIS, CHIN, INTERNAL
    Search all 15 clearances from Porex Medical →