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

    OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS

    K Number: K911110 · Decision Jun 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    38
    Applicant Total
    8
    Review Days
    106

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    Basic Information

    Device Name
    OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
    K Number
    K911110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    G.W.B. Intl., Ltd.
    Date Received
    March 4, 1991
    Decision Date
    June 18, 1991
    Product Code
    HPZ
    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
    HPZ Implant, Eye Sphere

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    Other Clearances by G.W.B. Intl., Ltd.

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    K954094 OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
    K950569 OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
    K940508 OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
    K911108 OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
    K911109 OPHTA SIL (R), LACHRYMAL INTUBATION SETS
    K896029 DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20