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

    SILS PORT, MODELS SILSPT5, SILSPT12

    K Number: K082619 · Decision Nov 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    SILS PORT, MODELS SILSPT5, SILSPT12
    K Number
    K082619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    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
    September 9, 2008
    Decision Date
    November 7, 2008
    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 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
    K090419 SILS STITCH ENDOSCOPIC SUTURING DEVICE
    K082659 MODIFIED ENDO STICH
    K081169 AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR