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

    PI-PHEUMO INTESTINAL INSTRUMENT SET

    K Number: K851121 · Decision Apr 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    6
    Review Days
    37

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    Basic Information

    Device Name
    PI-PHEUMO INTESTINAL INSTRUMENT SET
    K Number
    K851121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Surgeons Choice, Inc.
    Date Received
    March 19, 1985
    Decision Date
    April 25, 1985
    Product Code
    GAG
    Advisory Committee
    General Hospital
    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
    GAG Stapler, Surgical

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    Other Clearances by Surgeons Choice, Inc.

    K Number Device Name
    K851122 PI-PNEUMO INTESTINAL STAPLING CARTRIDGE
    K843399 SURGEONS CHOICE PI VASCULAR STAPLING
    K830768 DISPOSABLE SKIN STAPLER
    K823776 PI-PNEUMO-INTESTINAL INSTRUMENT SET
    K813170 ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER