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

    PENTAX Medical ED34-i10T, Video Duodenoscope

    K Number: K163614 · Decision Sep 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    272

    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
    PENTAX Medical ED34-i10T, Video Duodenoscope
    K Number
    K163614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Medical
    Date Received
    December 22, 2016
    Decision Date
    September 20, 2017
    Product Code
    FDT
    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
    FDT Duodenoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

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

    FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000

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

    Single Use Distal Cover MAJ-2315 (MAJ-2315)

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

    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)

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

    Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

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

    PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

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

    Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

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

    Other Clearances by Pentax Medical

    K Number Device Name
    K192280 PENTAX Medical ED-3490TK Video Duodenoscope
    K171011 PENTAX Medical VIVIDEO ENT Videoscope Solution
    K172156 PENTAX Medical EPK-3000 Video Imaging System
    K161222 PENTAX MEDICAL ED-3490TK, Video Duodenoscope
    K122470 PENTAX EPK-I5010 VIDEO PROCESSOR