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

    The ZIP Accessory Shuttle for PleuraFlow System

    K Number: K191733 · Decision Jul 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    The ZIP Accessory Shuttle for PleuraFlow System
    K Number
    K191733
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearflow, Inc.
    Date Received
    June 28, 2019
    Decision Date
    July 26, 2019
    Product Code
    OTK
    Advisory Committee
    General, Plastic Surgery
    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
    OTK Wound Drain Catheter System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OTK), ordered by most recent decision date.

    PleuraFlow System with FlowGlide

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PleuraFlow System with FlowGlide Extra Drainage Length

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PleuraFlow System with FlowGlide

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PleuraFlow System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PleuraFlow System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PLEURAFLOW CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Clearflow, Inc.

    K Number Device Name
    K203394 PleuraFlow System with FlowGlide
    K182067 PleuraFlow System with FlowGlide Extra Drainage Length
    K163139 PleuraFlow System with FlowGlide
    K153681 PleuraFlow System
    K150042 PleuraFlow System