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

    REUSABLE FIBEROPTIC LIGHTPIPE

    K Number: K881926 · Decision Jun 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    29
    Applicant Total
    64
    Review Days
    28

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    Basic Information

    Device Name
    REUSABLE FIBEROPTIC LIGHTPIPE
    K Number
    K881926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4690
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Products, Inc.
    Date Received
    May 9, 1988
    Decision Date
    June 6, 1988
    Product Code
    HQB
    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
    HQB Photocoagulator And Accessories

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    Other Clearances by Advanced Surgical Products, Inc.

    K Number Device Name
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    K884556 DREYER CURVED ENDOILLUMINATOR
    K890398 RYAN-STYLE DIRECTED INFUSION MANIPULATOR
    K884347 MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
    K883857 FIBEROPTIC WIRE PICK LIGHTPIPE
    K883858 FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
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