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510(k) Data Aggregation

    K Number
    K251156
    Device Name
    NPseal
    Manufacturer
    Guard Medical, Inc.
    Date Cleared
    2025-05-15

    (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. Each NPseal dressing is intended to be used up to 7 days. The total therapy time across multiple NPseal dressing changes is up to 14 days. NPseal therapy must be discontinued after 14 days. NPSeal dressing wear time 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 dressing change. - The NPseal 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm. - The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm. - The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm. - The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm. - The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.
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    K Number
    K250708
    Device Name
    NPseal
    Manufacturer
    Guard Medical, Inc.
    Date Cleared
    2025-04-08

    (29 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 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm. - The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm. - The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm. - The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm. - The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.
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    K Number
    K241522
    Device Name
    NPseal (20 and 25)
    Manufacturer
    Guard Medical, Inc.
    Date Cleared
    2024-08-15

    (78 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 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm. The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.
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