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

    REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)

    K Number: K933901 · Decision Nov 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    8
    Review Days
    101

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    Basic Information

    Device Name
    REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)
    K Number
    K933901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard-Allan Medical
    Date Received
    August 10, 1993
    Decision Date
    November 19, 1993
    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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    K924929 REFLEX(R) ECA
    K905682 RICHARD-ALLAN CLAMP COVERS
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