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

    DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES

    K Number: K934105 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    3
    Review Days
    217

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    Basic Information

    Device Name
    DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES
    K Number
    K934105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Innovations Corp.
    Date Received
    August 23, 1993
    Decision Date
    March 28, 1994
    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 Surgical Innovations Corp.

    K Number Device Name
    K944292 SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE
    K914098 LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR