Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
QFC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4783
Classification
FDA Product Code
QFC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4783
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.