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QFCClass II

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

21 CFR 878.4783 / General, Plastic Surgery
FDA source (opens on fda.gov)

QFC is the FDA product code for Negative Pressure Wound Therapy Device For Reduction Of Wound Complications, a class II device type, regulated under 21 CFR 878.4783. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QFC
Device name
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
FDA 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.
Regulation
21 CFR 878.4783
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code QFC

By decision year
3 clearances under product code QFC with a decision year between 2019 and 2023, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QFC by decision year
YearClearances
20191
20211
20231

Applicants with the most clearances

Product code QFC
Applicants holding the most 510(k) clearances under product code QFC
ApplicantClearances
3M1
KCI USA, Inc.1
Smith & Nephew Medical Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code