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

    EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7

    K Number: K061324 · Decision Jun 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    2
    Review Days
    40

    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
    EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
    K Number
    K061324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rtc Inc.-Memcath Technologies, LLC
    Date Received
    May 11, 2006
    Decision Date
    June 20, 2006
    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 Rtc Inc.-Memcath Technologies, LLC

    K Number Device Name
    K061663 ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES