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

    STATARIUS, MODEL 001 003

    K Number: K061292 · Decision Jul 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    2
    Review Days
    55

    Basic Information

    Device Name
    STATARIUS, MODEL 001 003
    K Number
    K061292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KINETIC SURGICAL LLC
    Date Received
    May 9, 2006
    Decision Date
    July 3, 2006
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

    Similar 510(k) Clearances

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

    Disposable Trocars

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

    8 mm Assist Cannula; 12 mm Assist Cannula

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

    Boehringer Laboratories Liver Retractor

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

    Medical Monitor (32HS710S)

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

    Arthrex Synergy Vision Endoscopic Imaging System

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

    LAGIS Suction Irrigation System

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

    Other Clearances by KINETIC SURGICAL LLC

    K Number Device Name
    K072811 MARIONETTE SA, MODEL 001 001 & 001 002