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510(k) Data Aggregation

    K Number
    K251923

    Validate with FDA (Live)

    Device Name
    Medical Shaver System (Morcellator) (YSB-IIIA)
    Manufacturer
    Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
    Date Cleared
    2026-01-29

    (220 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K041610,K192499
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.

    Device Description

    The device includes a control unit, handpiece, footswitch, blades, waste bottle, collection bottle, and suction tube. The device is a reusable morcellation device which is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures.

    AI/ML Overview

    N/A

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