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

    THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM

    K Number: K952563 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    24
    Review Days
    53

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    Basic Information

    Device Name
    THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
    K Number
    K952563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Tulip Mfg. Co.
    Date Received
    June 2, 1995
    Decision Date
    July 25, 1995
    Product Code
    GCT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCT Light Source, Endoscope, Xenon Arc

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    Other Clearances by The Tulip Mfg. Co.

    K Number Device Name
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    K955502 THE TULIP MONO POLAR ROTATABLE METZ SCISSORS
    K955501 THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP
    K952901 THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
    K954734 THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
    K952932 THE TULIP COMPANY BRANSON #1 ELEVATOR
    K952951 THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR
    K952953 THE TULIP CXOMPANY BRANSON #2 ELEVATOR
    K952902 THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR
    Search all 24 clearances from The Tulip Mfg. Co. →