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510(k) Data Aggregation

    K Number
    K210248
    Device Name
    Lab Bag with Fabric Pouch
    Manufacturer
    Advanced Medical Design Co., Ltd.
    Date Cleared
    2021-07-30

    (182 days)

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

    Advanced Medical Design Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of the tissue, organ or specimen during surgery.
    Device Description
    The Lap Bag with fabric pouch is applied in minimally invasive abdominal procedures for the safe and convenient removal of tissue, organ or specimens during surgery. The device is a TPU and nylon bonded fabric pouch that minimizes spillage and intraoperative contamination by isolating and containing tissue specimens. It is designed for introduction and use through 11/12 and 15mm cannula. The product is a single-use, sterile, and biocompatible laparoscopic accessory device. It is packaged by the Tyvek® 1073B sterile pouch and its shelf life is 3 years.
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    K Number
    K181887
    Device Name
    AMD Anti-Fog Solution
    Manufacturer
    Advanced Medical Design Co., Ltd
    Date Cleared
    2019-01-22

    (193 days)

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

    Advanced Medical Design Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.
    Device Description
    The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.
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