NRB · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4410
Classification
FDA Product Code
NRB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4410
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound