BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SoftFix Balloon Trocar

    K Number: K211577 · Decision Nov 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    7
    Review Days
    168

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    Basic Information

    Device Name
    SoftFix Balloon Trocar
    K Number
    K211577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unimax Medical Systems, Inc.
    Date Received
    May 21, 2021
    Decision Date
    November 5, 2021
    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 Unimax Medical Systems, Inc.

    K Number Device Name
    K103508 UNMIAX LAPAROSCOPIC INSTRUMENT
    K112358 UNIMAX TROCAR SYSTEM
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    K111441 UNIMAX VERESS NEEDLE
    K103509 UNIMAX SUCTION IRRIGATION SET
    K103510 UNIMAX SPECIMEN RETRIEVAL SYSTEM