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

    AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS

    K Number: K083519 · Decision Apr 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    7
    Review Days
    135

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    Basic Information

    Device Name
    AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
    K Number
    K083519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien Lp, Formerly Registered AS United States
    Date Received
    November 26, 2008
    Decision Date
    April 10, 2009
    Product Code
    GDW
    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
    GDW Staple, Implantable

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    Other Clearances by Covidien Lp, Formerly Registered AS United States

    K Number Device Name
    K091869 SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS
    K091900 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
    K090419 SILS STITCH ENDOSCOPIC SUTURING DEVICE
    K082619 SILS PORT, MODELS SILSPT5, SILSPT12
    K082659 MODIFIED ENDO STICH
    K081169 AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR