NRB

Wound Cleaner, Ultrasound

Product code

NRB

Device name

Wound Cleaner, Ultrasound

Device class

Class 2

21 CFR

21 CFR 878.4410

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).