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

    SURGIQUEST AIRSEAL IFS

    K Number: K132169 · Decision Aug 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    38

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    Basic Information

    Device Name
    SURGIQUEST AIRSEAL IFS
    K Number
    K132169
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgiquest, Inc.
    Date Received
    July 15, 2013
    Decision Date
    August 22, 2013
    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 Surgiquest, Inc.

    K Number Device Name
    K143404 SurgiQuest AirSeal iFS System
    K121336 MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
    K103692 SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
    K100180 SURGIQUEST ANCHORPORT SIL KIT
    K092504 SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
    K083211 AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
    K071571 SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
    K063859 SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA