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

    Tissue Removal Pouch

    K Number: K150781 · Decision Jun 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    Tissue Removal Pouch
    K Number
    K150781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Laboratories, LLC
    Date Received
    March 25, 2015
    Decision Date
    June 19, 2015
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Boehringer Laboratories, LLC

    K Number Device Name
    K243399 Boehringer Laboratories Liver Retractor
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