QFC · Class II · 21 CFR 878.4783

FDA Product Code QFC: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

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.

Leading manufacturers include Smith and Nephew Medical Limited and 3M.

3
Total
2
Cleared
290d
Avg days
2019
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Devices (Product Code QFC)

3 devices
1–3 of 3
Cleared Feb 13, 2023
Prevena Plus 125 Therapy Unit
K223263
3M
General & Plastic Surgery · 112d
Cleared Dec 14, 2021
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
K203716
Smith and Nephew Medical Limited
General & Plastic Surgery · 358d

About Product Code QFC - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QFC since 2019, with 2 receiving FDA clearance (average review time: 290 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QFC devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →