BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Flexible Overtube

    K Number: K182520 · Decision May 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    4
    Review Days
    244

    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
    Flexible Overtube
    K Number
    K182520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sumitomo Bakelite Co., Ltd.
    Date Received
    September 13, 2018
    Decision Date
    May 15, 2019
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

    Similar 510(k) Clearances

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

    CVAC Aspiration System

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

    ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

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

    Prodeon Urethral Sheath System

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

    Single Use Suction-Evacuation Ureteral Access Sheath

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

    Ureteral Access Sheath

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

    Single-use Ureteral Access Sheath

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

    Other Clearances by Sumitomo Bakelite Co., Ltd.

    K Number Device Name
    K190621 SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
    K173004 SB Soft Hood - Straight type, SB Soft Hood - Undercut type
    K152771 SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long