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

    ETHICON LINX® Esophagus Sizing Tool

    K Number: K230089 · Decision Feb 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    28

    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
    ETHICON LINX® Esophagus Sizing Tool
    K Number
    K230089
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5360
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Torax Medical, Inc.
    Date Received
    January 12, 2023
    Decision Date
    February 9, 2023
    Product Code
    QJN
    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
    QJN Laparoscopic Accessories, Esophageal Sizing

    Similar 510(k) Clearances

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

    ETHICON Linx Esophagus Sizing Tool

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

    Other Clearances by Torax Medical, Inc.

    K Number Device Name
    K201035 ETHICON Linx Esophagus Sizing Tool