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

    SurgiQuest AirSeal iFS System

    K Number: K143404 · Decision Mar 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    9
    Review Days
    112

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    Basic Information

    Device Name
    SurgiQuest AirSeal iFS System
    K Number
    K143404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgiquest, Inc.
    Date Received
    November 28, 2014
    Decision Date
    March 20, 2015
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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    Other Clearances by Surgiquest, Inc.

    K Number Device Name
    K132169 SURGIQUEST AIRSEAL IFS
    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