DeviceClearance

Product code NRB— General, Plastic Surgery

AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM

Classification name
Wound Cleaner, Ultrasound
Device class
Class 2
Regulation
21 CFR 878.4410
Advisory panel
General, Plastic Surgery
Total cleared
9
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code NRB under 21 CFR 878.4410, via openFDA

Market context for product code NRB

FDA has cleared 9 devices under product code NRB between 2004 and 2016, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NRB

Adverse events under product code NRB

product code NRB
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NRB

Data sourced from openFDA. This site is unofficial and independent of the FDA.