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

    SURGEONS CHOICE PI VASCULAR STAPLING

    K Number: K843399 · Decision Nov 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    SURGEONS CHOICE PI VASCULAR STAPLING
    K Number
    K843399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgeons Choice, Inc.
    Date Received
    August 30, 1984
    Decision Date
    November 5, 1984
    Product Code
    GDW
    Advisory Committee
    General, Plastic Surgery
    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
    GDW Staple, Implantable

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    Other Clearances by Surgeons Choice, Inc.

    K Number Device Name
    K851121 PI-PHEUMO INTESTINAL INSTRUMENT SET
    K851122 PI-PNEUMO INTESTINAL STAPLING CARTRIDGE
    K830768 DISPOSABLE SKIN STAPLER
    K823776 PI-PNEUMO-INTESTINAL INSTRUMENT SET
    K813170 ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER