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510(k) Data Aggregation

    K Number
    K240244
    Device Name
    NPseal (Small, Medium, Large)
    Manufacturer
    Guard Medical Inc.
    Date Cleared
    2024-02-29

    (30 days)

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

    Guard Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
    Device Description
    The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 7 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change. The NPseal Small is intended to remove small amounts of exudate from surgically closed incisions up to 5 cm × 0.5 cm. The NPseal Medium is intended to remove small amounts of exudate from surgically closed incisions up to 10 cm x 0.5 cm. The NPseal Large is intended to remove small amounts of exudate from surgically closed incisions up to 15 cm x 0.5 cm.
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    K Number
    K212971
    Device Name
    NPseal
    Manufacturer
    Guard Medical Inc
    Date Cleared
    2022-02-10

    (146 days)

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

    Guard Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NPseal is indicated for patients who would management via application of a negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
    Device Description
    The NPseal Neqative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 6 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal Small is intended for surgically closed incisions up to 5cm x 0.5 cm The NPseal Medium is intended for surgically closed incisions up to 10 cm x 0.5 cm. The NPseal Large is intended for surgically closed incisions up to 15 cm x 0.5 cm.
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    K Number
    K211130
    Device Name
    NPseal
    Manufacturer
    Guard Medical Inc.
    Date Cleared
    2021-05-14

    (28 days)

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

    Guard Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
    Device Description
    The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 6 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing result in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.
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    K Number
    K200305
    Device Name
    NPseal
    Manufacturer
    Guard Medical Inc.
    Date Cleared
    2020-05-26

    (110 days)

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

    Guard Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
    Device Description
    The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHq to -125 mmHq nominal range. The NPseal is intended for 3 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing results in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.
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