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

    DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS

    K Number: K120258 · Decision Feb 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    13
    Review Days
    33

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    Basic Information

    Device Name
    DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
    K Number
    K120258
    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, Formerly US Surgical A Divison of Tyco H
    Date Received
    January 27, 2012
    Decision Date
    February 29, 2012
    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, Formerly US Surgical A Divison of Tyco H

    K Number Device Name
    K131705 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
    K130532 IDRIVE ULTRA STERILIZATION TRAY
    K130717 ENDO GIA RELOAD
    K130435 VERSAPORT V2 BLADELESS OPTICAL TROCAR
    K122781 RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
    K123318 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
    K121510 IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
    K120061 WOUND PROTECTOR
    K111825 ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
    K112349 VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
    Search all 13 clearances from Covidien, Formerly US Surgical A Divison of Tyco H →