BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Green OR Reprocessed Aquamantys Bipolar Sealer

    K Number: K211203 · Decision Apr 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    350

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    Basic Information

    Device Name
    Green OR Reprocessed Aquamantys Bipolar Sealer
    K Number
    K211203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Green Or, LLC
    Date Received
    April 22, 2021
    Decision Date
    April 7, 2022
    Product Code
    NUJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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