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

    PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK

    K Number: K875004 · Decision Mar 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    64
    Review Days
    101

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    Basic Information

    Device Name
    PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
    K Number
    K875004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Products, Inc.
    Date Received
    December 4, 1987
    Decision Date
    March 14, 1988
    Product Code
    FST
    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
    FST Light, Surgical, Fiberoptic

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    Other Clearances by Advanced Surgical Products, Inc.

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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
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