LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980930
    Device Name
    FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1998-09-22

    (194 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA

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

    The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues as used in the following surgical areas:

    • (a) Neurosurgery
    • (b) Gastrointestinal and affiliated organ surgery
    • (c) Urological surgery
    • (d) Plastic and reconstructive surgery
    • (e) Gynecological procedures
    • (f) Orthopedic Surgery
      These indicated uses are equivalent to the predicate device. Appropriate warnings and cautions are indicated in the Operator's Manual.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Fibra Sonics Ultrasonic Surgical Aspirator System Model 2100 USSTA." This letter is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information from the given input. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1