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510(k) Data Aggregation

    K Number
    K253429

    Validate with FDA (Live)

    Date Cleared
    2026-03-12

    (162 days)

    Product Code
    Regulation Number
    878.4780
    Age Range
    18 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Genadyne Astra NPWT System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device can be used for wound management by the removal of excess exudates, infectious material and tissue debris.

    Appropriate wound type include:

    • Chronic
    • Acute
    • Traumatic
    • Subacute and dehisced wounds
    • Partial thickness burns
    • Ulcers (such as diabetic or pressure)
    • Flaps and grafts

    For use by healthcare professional and home use. This NPWT System can only be used with approved dressing kits under K233614.

    Device Description

    The Genadyne ASTRA NPWT is a Negative Pressure Wound Therapy. The ASTRA NPWT features an interface touch panel which provides user selectable therapy modes (continuous mode and variable mode) and multi pressure options from 40mmHg to 200 mmHg). The ASTRA NPWT is packaged in a box that includes a universal charger, power cable, a user manual and a user carry bag. The dressing kits (approved under K233614) includes the transparent film dressings, the Genadyne foam dressing and the Genadyne Port. The Genadyne ASTRA NPWT is designed to be used with a canister collection system. The canister will have 3 sizes available (200cc, 400cc and 600cc).

    All the dressings and canisters are single use disposable items. To help ensure safe and effective use, the ASTRA NPWT are to be used only with the Genadyne supplied dressings (approved under K233614) and canisters. For our bench test, the ASTRA NPWT was tested with the Genadyne green thick foam dressing kit.

    AI/ML Overview

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