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

    POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT

    K Number: K863946 · Decision Feb 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    15
    Review Days
    140

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    Basic Information

    Device Name
    POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
    K Number
    K863946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3340
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Porex Medical
    Date Received
    October 10, 1986
    Decision Date
    February 27, 1987
    Product Code
    HQX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQX Implant, Orbital, Extra-Ocular

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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
    K870154 POREX(TM) TISSUE EXPANDER
    K870182 POREX(TM) MALAR IMPLANT
    K870257 POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
    K863939 POREX(TM) EAR PROSTHESIS
    K863942 POREX(TM) NOSE PROSTHESIS
    K863941 POREX(TM) PROSTHESIS, CHIN, INTERNAL
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