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

    AUTO SUTURE PITUITARY SPINAL RONGEUR

    K Number: K943115 · Decision Jul 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    33
    Applicant Total
    218
    Review Days
    28

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    Basic Information

    Device Name
    AUTO SUTURE PITUITARY SPINAL RONGEUR
    K Number
    K943115
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.4535
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    June 27, 1994
    Decision Date
    July 25, 1994
    Product Code
    HAO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAO Instrument, Surgical, Non-Powered

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    K061095 AUTO SUTUR ENDO GIA STAPLERS
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    K040594 HERCULON SOFT TISSUE REATTACHMENT SYSTEM
    K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
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