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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 apparatus
Regulation Description Non-Powered suction apparatus device intended for negative pressure wound therapy.
Definition A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended 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.
Physical State Mechanical 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 drives the wound exudate to be pumped from the wound bed into a collection canister. It is designed to provide a pre-set level of negative pressure to the wound bed.
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 CodeOKO
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive 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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible