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510(k) Data Aggregation

    K Number
    K983200
    Device Name
    INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-12-11

    (88 days)

    Product Code
    GAA
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K102274
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.

    Device Description

    Injection/Aspiration Needles Probes/Devices

    AI/ML Overview

    The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for "Injection/Aspiration Needle Probes/Devices." It states that the devices are substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes used for testing, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth used, or training set details.

    Therefore, I cannot extract the requested information from the provided text. The document's purpose is to grant market clearance based on substantial equivalence, not to detail the performance study results.

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