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U.S. Department of Health and Human Services

Product Classification

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Device negative pressure wound therapy, non-powered suction pump, chemical
Regulation Description Non-Powered suction apparatus device intended for negative pressure wound therapy.
Definition For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Physical State Pump and wound dressing kit
Technical Method The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions). The suction apparatus is engaged to create a vacuum (negative pressure) within the wound bed which drives the wound exudate to be pumped from the wound bed into a collection canister or the dressing. It is designed to provide a pre-set level of negative pressure to the wound bed. The negative pressure is generated by a chemical reaction.
Target Area For management of chronic, acute, traumatic, subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure) flaps and grafts.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQPX
Premarket Review Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4683
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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