NRB · Class II · 21 CFR 878.4410

FDA Product Code NRB: Wound Cleaner, Ultrasound

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

Leading manufacturers include Celleration, Inc., Arobella Medical, LLC and Misonix, Inc..

9
Total
8
Cleared
112d
Avg days
2004
Since

FDA 510(k) Cleared Wound Cleaner, Ultrasound Devices (Product Code NRB)

9 devices
1–9 of 9
Cleared Dec 22, 2016
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
K162721
Alliqua Biomedical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 13, 2014
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
K140782
Celleration, Inc.
General & Plastic Surgery · 135d
Cleared May 16, 2014
AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
K131096
Arobella Medical, LLC
General & Plastic Surgery · 393d
Cleared Mar 05, 2013
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
K123980
Misonix, Inc.
General & Plastic Surgery · 69d
Cleared Aug 13, 2012
MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
K122246
Celleration, Inc.
General & Plastic Surgery · 17d
Cleared Dec 01, 2011
MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
K112782
Misonix, Inc.
General & Plastic Surgery · 66d
Cleared Jun 19, 2009
AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
K091038
Arobella Medical, LLC
General & Plastic Surgery · 67d
Cleared May 17, 2005
CELLERATION MIST THERAPY SYSTEM 5.1
K050129
Celleration, Inc.
General & Plastic Surgery · 118d
Not Cleared Jun 25, 2004
CELLERATION MIST THERAPY SYSTEM
DEN040004
Celleration
General & Plastic Surgery · 57d

About Product Code NRB - Regulatory Context