LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152400
    Device Name
    General & Plastic Surgery Instruments
    Manufacturer
    Sontec Instruments Inc.
    Date Cleared
    2016-01-22

    (150 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sontec Instruments Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.
    Device Description
    Sontec Instruments are a family of manual, instruments consisting of Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips. These reusable devices are packaged non-sterile and are steam sterilizable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1