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510(k) Data Aggregation

    K Number
    K111979
    Device Name
    RADIOACTIVE SEED LOCALIZATION NEEDLE
    Manufacturer
    BIOCOMPATIBLES INC.
    Date Cleared
    2011-10-18

    (98 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K122704,K141701,K161902
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the localization of suspicious tissues (non-palpable lesions) for excision in the use of radioactive seeds.

    Device Description

    BrachySciences Radioactive Seed Localization Needle with AnchorSeed.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "BrachySciences Radioactive Seed Localization Needle with AnchorSeed," along with its "Indications For Use" statement.

    This document does not describe:

    • Acceptance criteria for a device's performance (beyond the general regulatory requirement of substantial equivalence).
    • Any specific study that proves the device meets particular performance criteria.
    • Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

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