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

    SILS STITCH ENDOSCOPIC SUTURING DEVICE

    K Number: K090419 · Decision Mar 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    7
    Review Days
    19

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    Basic Information

    Device Name
    SILS STITCH ENDOSCOPIC SUTURING DEVICE
    K Number
    K090419
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien Lp, Formerly Registered AS United States
    Date Received
    February 18, 2009
    Decision Date
    March 9, 2009
    Product Code
    OCW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCW Endoscopic Tissue Approximation Device

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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
    K083519 AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
    K082619 SILS PORT, MODELS SILSPT5, SILSPT12
    K082659 MODIFIED ENDO STICH
    K081169 AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR