Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K211197
    Device Name
    Disposable Endoscopic Cutter Stapler and Cartridge
    Manufacturer
    Changzhou Waston Medical Appliance Co., Ltd
    Date Cleared
    2023-01-19

    (638 days)

    Product Code
    GDW, GAG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Waston Medical Appliance Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.
    Device Description
    Disposable Endoscopic Cutter Stapler and Cartridge place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths with cartridge in 2.0/2.5/3.0, 3.0/3.5/4.0, 4.0/4.5/5.0 three progressive staple sizes to accommodate carious tissue thickness. The device may be reloaded and fired up to 12 times in a single procedure.
    Ask a Question
    K Number
    K151062
    Device Name
    WASTON Metallic Intramedullary Nail System
    Manufacturer
    CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
    Date Cleared
    2015-12-17

    (241 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simple, compound first- and second-degree tibial shaft fractures Pseudarthrosis and delayed union
    Device Description
    The WASTON Metallic Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections. All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136. The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
    Ask a Question

    Page 1 of 1