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510(k) Data Aggregation
K Number
K251156Device Name
NPseal
Manufacturer
Guard Medical, Inc.
Date Cleared
2025-05-15
(30 days)
Product Code
OKO
Regulation Number
878.4683Why 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
K250708Device Name
NPseal
Manufacturer
Guard Medical, Inc.
Date Cleared
2025-04-08
(29 days)
Product Code
OKO
Regulation Number
878.4683Why 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
K241522Device Name
NPseal (20 and 25)
Manufacturer
Guard Medical, Inc.
Date Cleared
2024-08-15
(78 days)
Product Code
OKO
Regulation Number
878.4683Why 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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