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U.S. Department of Health and Human Services

Product Classification

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Device negative pressure wound therapy device for reduction of wound complications
Definition A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.
Physical State The device is a portable suction pump with a canister for fluid collection.
Technical Method The device, when used with legally marketed compatible dressings, applies negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials.
Target Area The device, when used with legally marketed compatible dressings, is intended to be applied to closed surgical incisions after surgery.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQFC
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery (DHT4B)
Submission Type 510(k)
Regulation Number 878.4783
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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