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

    THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)

    K Number: K954734 · Decision Nov 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    24
    Review Days
    42

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
    K Number
    K954734
    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
    October 3, 1995
    Decision Date
    November 14, 1995
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FET), ordered by most recent decision date.

    ProVee Video Processing Unit (PV-003)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoscopic Camera System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoscopic Video Image Processor (RP-IPD-V1000F)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by The Tulip Mfg. Co.

    K Number Device Name
    K952959 THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK
    K952906 THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK
    K955502 THE TULIP MONO POLAR ROTATABLE METZ SCISSORS
    K955501 THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP
    K952901 THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
    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
    K952958 THE TULIP COMPANY BRANSON OVERSHEATH
    Search all 24 clearances from The Tulip Mfg. Co. →