BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GORE INTRODUCER SHEATH

    K Number: K013282 · Decision Dec 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    163
    Review Days
    73

    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
    GORE INTRODUCER SHEATH
    K Number
    K013282
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    October 2, 2001
    Decision Date
    December 14, 2001
    Product Code
    DBY
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DBY Fab, Rhodamine, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    CONVOY ADVANCED DELIVERY SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER

    FDA 510(k)
    FDA Class 1 ·Immunology

    CONVOY ADVANCED DELIVERY SHEATH KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    RHODAMINE-CONJUGATED ANTISERUM

    FDA 510(k)
    FDA Class 1 ·Immunology
    View all

    Other Clearances by W. L. Gore & Associates, Inc.

    K Number Device Name
    K250410 GORE® Tri-Lobe Balloon Catheter
    K240083 GORE® PROPATEN® Vascular Graft
    K232312 GORE® PROPATEN® Vascular Graft
    K233551 GORE® ACUSEAL Vascular Graft
    K231505 GORE® ACUSEAL Vascular Graft
    K191773 GORE BIO-A Tissue Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K173333 GORE ENFORM Biomaterial
    K163576 GORE SYNECOR Preperitoneal Biomaterial
    K170740 GORE VIABIL Short Wire Biliary Endoprosthesis
    Search all 163 clearances from W. L. Gore & Associates, Inc. →