BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Arc Enterocuff

    K Number: K191330 · Decision Jan 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    260

    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
    Arc Enterocuff
    K Number
    K191330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boddingtons Plastics, Ltd.
    Date Received
    May 16, 2019
    Decision Date
    January 31, 2020
    Product Code
    FDA
    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
    FDA Enteroscope And Accessories

    Similar 510(k) Clearances

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

    Ancora-SB

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

    FUJIFILM Stiffening Wire Device (SW-2000)

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

    Double Balloon Endoscope EN-840T, Over-tube TS-1214C

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

    Ancora-SB

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

    Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

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

    Balloon BS-3

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

    Other Clearances by Boddingtons Plastics, Ltd.

    K Number Device Name
    K191067 Arc Endocuff Glide AEG110 & AEG120
    K162205 Arc EndoCuff and Arc EndoCuff Vision
    K151801 Arc Endocuff Vision
    K122565 ARC ENDOCUFF