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

    PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE

    K Number: K073671 · Decision Mar 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    6
    Review Days
    90

    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
    PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
    K Number
    K073671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ndo Surgical, Inc.
    Date Received
    December 27, 2007
    Decision Date
    March 26, 2008
    Product Code
    OCW
    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
    OCW Endoscopic Tissue Approximation Device

    Similar 510(k) Clearances

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

    Endomina EZFuse system

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

    SimpleStitch Suturing System

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

    MaxTack™ Motorized Fixation Device

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

    MedicloseTM System

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

    OverStitch NXT Endoscopic Suturing System

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

    endomina system

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

    Other Clearances by Ndo Surgical, Inc.

    K Number Device Name
    K072125 ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
    K071553 ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
    K032820 MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
    K031262 ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
    K023234 ENDOSCOPIC PLICATION SYSTEM