NRBClass II

Wound Cleaner, Ultrasound

21 CFR 878.4410 / General, Plastic Surgery

NRB is the FDA product code for Wound Cleaner, Ultrasound, a class II device type, regulated under 21 CFR 878.4410. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2016-12-22, and no recalls.

Classification record

Product code: NRB
Device name: Wound Cleaner, Ultrasound
FDA 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
Regulation: 21 CFR 878.4410
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: Yes
Ingested clearances: 9
Ingested recalls: 0

Clearances, product code NRB

By decision year

9 clearances under product code NRB with a decision year between 2004 and 2016, 2014 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NRB by decision year
Year	Clearances
2004	1
2005	1
2009	1
2011	1
2012	1
2013	1
2014	2
2016	1

Applicants with the most clearances

Product code NRB

Applicants holding the most 510(k) clearances under product code NRB
Applicant	Clearances
Celleration, Inc.	4
Arobella Medical, LLC	2
Misonix, LLC	2
Alliqua Biomedical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code