Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
The 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, removing wound exudate, irrigation fluids, and infectious materials; it is intended for use with wound dressings classified under 21 CFR 878.4780 and does not include devices for organ space wounds. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 878.4783 in the General and Plastic Surgery specialty. The product code is QFC. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFC
- Device Class
- FDA class 2
- Regulation Number
- 878.4783
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223263 | Prevena Plus 125 Therapy Unit | Feb 13, 2023 | Substantially Equivalent | 3M |
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | Dec 14, 2021 | Substantially Equivalent | Smith and Nephew Medical Limited |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Apr 19, 2019 | Unknown | Kci USA, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.