BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    UNIMICRO SUCTION IRRIATION TUBING SET

    K Number: K141592 · Decision Aug 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    52

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    Basic Information

    Device Name
    UNIMICRO SUCTION IRRIATION TUBING SET
    K Number
    K141592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unimicro Medical Systems (Shenzhen) Co., Ltd.
    Date Received
    June 13, 2014
    Decision Date
    August 4, 2014
    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 Unimicro Medical Systems (Shenzhen) Co., Ltd.

    K Number Device Name
    K141594 Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
    K150068 Unimicro Veress Needle
    K142208 Monopolar Laparascopic Accessories
    K141593 UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH