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

    FLEXIBLE ILLUMINATOR 15

    K Number: K840372 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    31
    Review Days
    88

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    Basic Information

    Device Name
    FLEXIBLE ILLUMINATOR 15
    K Number
    K840372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Suncoast Medical Manufacturers, Inc.
    Date Received
    January 27, 1984
    Decision Date
    April 24, 1984
    Product Code
    FTF
    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
    FTF Illuminator, Non-Remote

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    Other Clearances by Suncoast Medical Manufacturers, Inc.

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    K841603 ADJUST-A-TEMP MICRO
    K841591 PYRO-TIP
    K840376 SURG-A STAT LOOP TIP
    K840375 SURG-A-STAT LOOP TIP 15
    K840387 SURG-A-STAT LOOP TIP 2
    K840370 SURG-A-STAT VASECTOMY TIP
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