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510(k) Data Aggregation

    K Number
    K251140
    Manufacturer
    Date Cleared
    2025-09-23

    (162 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zenflow Spring Scope is a sterile, single use flexible cystoscope intended to provide endoscopic access and visualization of the lower urinary tract. The Zenflow Spring Scope is intended for use with the separately provided Zenflow Camera Control Unit and which provides visualization via any commercially compatible video monitor. The Zenflow Spring Scope can be used with compatible endoscopic accessories.

    The Zenflow Spring Scope is intended for use in a hospital environment or medical office environment.

    The Zenflow Spring Scope is designed for use in adults.

    Device Description

    The Zenflow Spring Scope is a sterile, single-use flexible cystoscope which is compatible only with the separately provided Zenflow Camera Control Unit (CCU), which provides direct visualization of the lower urinary tract via any commercially compatible video monitor. The Zenflow Spring Scope (Spring Scope) incorporates markings on the shaft along with a slider that may be used to reference anatomical positions. The Spring Scope has a lever that enables anterior steering, and a built-in steering lock which holds the Spring Scope in a deflected (anterior) position. The working channel provides access for compatible endoscopic devices and instrumentation. The Spring Scope is for single patient use only.

    The Spring Scope houses a CMOS-based imaging sensor and LED for anatomic visualization. Cystoscopic digital imaging allows for direct visualization of the bladder and urethra. The Spring Scope handle also contains a luer port which is used to connect with an irrigation line.

    AI/ML Overview

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