BEUDAMED
    Product Code: QAU FDA class 2 21 CFR 878.4456

    Hemostatic Device For Endoscopic Gastrointestinal Use

    General, Plastic Surgery

    The Hemostatic Device for Endoscopic Gastrointestinal Use is a prescription device endoscopically applied to the upper and/or lower gastrointestinal tract to produce hemostasis via absorption of fluid or other physical means, used for the control of gastrointestinal bleeding. It is classified as a Class 2 device under regulation 878.4456, requiring 510(k) premarket notification, and falls within the General, Plastic Surgery (SU) medical specialty. The product code is QAU. It is flagged as an implant, reflecting its intraluminal placement within the GI tract.

    View on FDA
    510(k)s
    11
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    6
    Years Active
    8

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    Basic Information

    Product Code
    QAU
    Device Class
    FDA class 2
    Regulation Number
    878.4456
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K253302 Hemospray Endoscopic Hemostat (HEMO-[X])
    K253924 PuraStat
    K240994 Nexpowder
    K242250 PuraStat
    K234131 Resolv Endoscopic Hemostat System
    K222481 PuraStat
    K202929 Nexpowder
    K210098 PuraStat-GI
    K190677 EndoClot
    K200972 Hemospray Endoscopic Hemostat
    DEN170015 Hemospray Endoscopic Hemostat

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.