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510(k) Data Aggregation

    K Number
    K981256
    Device Name
    ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-05-12

    (40 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    electrosurgical probes and devices are to be used with The commercially available R.F. generators, endoscopes including laparoscopes, hysteroscopes, resectoscopes, cystoscopes and suction/irrigation systems. These devices can be used for lappeoscopic. hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.

    Device Description

    Isolated Electrosurgical Probes & Devices-Salinetrode™M (cutting loops, roller balls, roller bars/barrels, and needles/blades)

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The document is an FDA 510(k) clearance letter for an electrosurgical device, confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include data from a clinical or performance study.

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