FDA product code QFC

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

General, Plastic Surgery·Class 2·21 CFR 878.4783
US regulatory classifications
US Product Code (FDA)
QFC
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4783
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.