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510(k) Data Aggregation

    K Number
    K253525

    Validate with FDA (Live)

    Date Cleared
    2026-03-12

    (119 days)

    Product Code
    Regulation Number
    876.5510
    Age Range
    45 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Urocross Expander System is intended to relieve urinary outflow obstruction. The Urocross Expander System is indicated for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) in men ≥ 45 years old.

    The Urocross Expander Implant is indicated for an indwell duration of up to 6 months.

    Device Description

    The Urocross Expander System is a temporary implantable urethral opening system. The Urocross Expander System consists of a sterile, single-use nitinol tissue expander (Urocross Expander Implant) preloaded in a catheter delivery system. The delivery system is made of biocompatible materials widely used in the manufacture of medical devices such as Pebax, stainless steel, polycarbonate, PTFE, PEEK, and nylon. The Urocross Expander System is designed to be advanced through the instrument channel (central through lumen) of a commercially available flexible cystoscope. The Urocross Expander Implant is then delivered and deployed under cystoscopic visualization in the prostatic urethra. Once deployed in the target location, the expansive strength and stiffness of the Urocross Expander Implant push the lateral lobes apart, increasing the opening of the prostatic urethra lumen, thereby improving urine flow and providing relief from LUTS.

    The Urocross Expander Implant is available in two sizes, small (20 mm length x 18 mm diameter, Model Number ES2018) and large (30 mm length x 25 mm diameter, Model Number ES3025). The small size is intended for prostatic urethral lengths of 25-45 mm, and the large size is intended for prostatic urethral lengths of 40 - 60 mm. The Urocross Expander Implant is designed to be in situ for up to 6 months and retrieved any time during the in-dwell period. Retrieval may be done using the Prodeon Urethral Sheath System and commercially available compatible cystoscopes and graspers commonly used during urological procedures.

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