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

    AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II

    K Number: K940398 · Decision Apr 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    218
    Review Days
    70

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    Basic Information

    Device Name
    AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
    K Number
    K940398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    January 27, 1994
    Decision Date
    April 7, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by United States Surgical, A Division of Tyco Healthc

    K Number Device Name
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    K061288 AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
    K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
    K062326 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
    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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