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

    AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR

    K Number: K914190 · Decision May 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    218
    Review Days
    231

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    Basic Information

    Device Name
    AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
    K Number
    K914190
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    September 18, 1991
    Decision Date
    May 6, 1992
    Product Code
    GAD
    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
    GAD Retractor

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    K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
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    K061095 AUTO SUTUR ENDO GIA STAPLERS
    K050947 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    K042412 MODIFIED SPACEMAKER SYSTEM
    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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