Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102274
    Device Name
    ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
    Manufacturer
    ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES
    Date Cleared
    2011-06-15

    (308 days)

    Product Code
    GAA
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.
    Device Description
    The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12 inches in overall length. The proximal end of the device is fitted with a luer adapter which is fitted to a standard syringe (not supplied with the device). Using the standard syringe, the device is used to aspirate small volumes of fluid during either open or laparoscopic procedures. The device has a chisel-point tip to allow for percutaneous application. To maintain the position of the needle tip during multiple aspirations, the distal end of the needle is equipped with expandable wire cage/balloon which secures the needle to small structures being aspirated (e.g., the gallbladder). Use of the security feature is optional on the part of the user.
    Ask a Question

    Page 1 of 1