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

    Unimicro Veress Needle

    K Number: K150068 · Decision Jul 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    5
    Review Days
    199

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    Basic Information

    Device Name
    Unimicro Veress Needle
    K Number
    K150068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unimicro Medical Systems (Shenzhen) Co., Ltd.
    Date Received
    January 13, 2015
    Decision Date
    July 31, 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 Unimicro Medical Systems (Shenzhen) Co., Ltd.

    K Number Device Name
    K141594 Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
    K142208 Monopolar Laparascopic Accessories
    K141593 UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
    K141592 UNIMICRO SUCTION IRRIATION TUBING SET