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510(k) Data Aggregation

    K Number
    K191505
    Device Name
    Rezum System
    Manufacturer
    NxThera (A Boston Scientific Company)
    Date Cleared
    2019-08-02

    (57 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NxThera (A Boston Scientific Company)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
    Device Description
    The reusable Rezum Generator is provided with the following reusable components: - Generator - One Power Cord The single-use Rezum Delivery Device contains the following disposable components: - One sterile Delivery Device with integrated cable and tubing - One sterile Syringe - One sterile Spike Adaptor - One 50 ml Sterile Water Vial
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    K Number
    K190093
    Device Name
    Rezum Delivery Device, Rezum Generator
    Manufacturer
    NxThera (A Boston Scientific Company)
    Date Cleared
    2019-03-25

    (66 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NxThera (A Boston Scientific Company)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
    Device Description
    The reusable Rezūm Generator is provided with the following reusable components: - Generator - One Power Cord The single-use Rezum Delivery Device contains the following disposable components: - One sterile Delivery Device with integrated cable and tubing - One sterile Syringe - One sterile Spike Adaptor - One 50 ml Sterile Water Vial
    Ask a Question

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