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

    IDRIVE ULTRA STERILIZATION TRAY

    K Number: K130532 · Decision May 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    13
    Review Days
    90

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    Basic Information

    Device Name
    IDRIVE ULTRA STERILIZATION TRAY
    K Number
    K130532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, Formerly US Surgical A Divison of Tyco H
    Date Received
    March 1, 2013
    Decision Date
    May 30, 2013
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Covidien, Formerly US Surgical A Divison of Tyco H

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    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
    K120258 DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
    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 →