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510(k) Data Aggregation

    K Number
    K250522
    Device Name
    Multi4 System
    Manufacturer
    Multi4 Medical AB
    Date Cleared
    2025-06-27

    (126 days)

    Product Code
    FAS, FBK, FJL, GEI, KQT
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Multi4 Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.
    Device Description
    The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs). The Multi4 System consists of the following components: • Multi4 Pump (with Integrated Fluid Control) o Footswitch • Multi4 B o Resectoscope & Needle o Simple4tainer (For collection of gross resected tissue pieces for pathology)
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