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

    BOWEN SUTURE PASSER

    K Number: K863146 · Decision Sep 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    2
    Applicant Total
    14
    Review Days
    21

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    Basic Information

    Device Name
    BOWEN SUTURE PASSER
    K Number
    K863146
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Bowen & Company, Inc.
    Date Received
    August 15, 1986
    Decision Date
    September 5, 1986
    Product Code
    HXI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HXI Passer, Wire, Orthopedic

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    K872098 CREMEEN ALVEOLAR BONE CALIPER
    K871325 BOWEN REUSEABLE/DISPOSABLE ELECTRODE
    K870882 45 DEGREE SHAVER
    K870881 LOOSE BODY GRASPERS
    K863148 BOWEN KNOT PASSER
    K863149 BOWEN PROBE
    K863147 GLENOID DRILL
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