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510(k) Data Aggregation

    K Number
    K161421
    Device Name
    Single Use Surgical Suction Irrigator
    Manufacturer
    JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD.
    Date Cleared
    2016-06-24

    (32 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K250130
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Surgical Suction is indicated to provide suction and irrigation functions in general surgery and laparoscopic surgery to help remove dropsy, hematocele and tissue debris by vacuum aspiration and deliver irrigation fluids to surgical site.

    Device Description

    Single Use Surgical Suction Irrigator, models: JM-CX1A, JM-CX4, JM-CX4B

    AI/ML Overview

    This document is a 510(k) clearance letter for a "Single Use Surgical Suction Irrigator." It does not contain information about acceptance criteria or a study that proves the device meets those criteria. The letter confirms substantial equivalence to a predicate device but does not detail performance testing results. Therefore, I cannot provide the requested information based on the provided text.

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