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510(k) Data Aggregation

    K Number
    K201400
    Device Name
    npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
    Manufacturer
    Date Cleared
    2021-08-23

    (452 days)

    Product Code
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aatru Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from wound management via application of negative pressure, as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate from closed surgical incisions.
    Device Description
    The npSIMS Negative Pressure Surgical Incision Management System™ by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile vacuum chamber and sterile dressing and tubing kit. The npSIMS is intended for use with closed incisions with low exudate up to 10ml, or over a period of up to 7 days. The disposable vacuum chamber initially generates a peak negative pressure of -100±5mmHg at the wound surface, and maintains a continuous, linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg ± 20mmHg). Wound exudate is managed by the absorptive dressing technology. The tubing can be cut to length based upon patient needs. Making use of a fully pre-assembled wound contact dressing, the npSIMS operates silently without the use of an external electromechanical pump nor collection canister, enabling discrete patient portability. The duration of treatment is dependent upon the recommendation of the treating physician. After use, all components of the npSIMS are disposed of as clinical waste in accordance with local protocols and regulations.
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