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510(k) Data Aggregation

    K Number
    K150067
    Device Name
    OTSC Proctology
    Manufacturer
    OVESCO ENDOSCOPY AG
    Date Cleared
    2015-09-16

    (246 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OTSC Proctology

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

    The OTSC Proctology instrument is indicated for compression of tissue in the anal and rectum, for treating wall lesions or for haemostasis other than hemorrhoids in proctology.

    The OTSC Proctology clip is indicated for placement within the anal and rectum for the purpose of treating mucosal/submucosal defects

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the OTSC Proctology device, indicating its substantial equivalence to a legally marketed predicate device.

    It primarily covers:

    • The FDA's review and determination of substantial equivalence.
    • Regulatory class and product code.
    • General controls provisions of the Act.
    • Contact information for FDA divisions.
    • Indications for Use for the OTSC Proctology device.

    There is no mention of specific acceptance criteria, device performance results, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for any study.

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