NRB — Wound Cleaner, Ultrasound Class II
Classification Details
- Product Code
- NRB
- Device Class
- Class II
- Regulation Number
- 878.4410
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K162721 | alliqua biomedical | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicato | December 22, 2016 |
| K140782 | celleration | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLI | August 13, 2014 |
| K131096 | arobella medical | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | May 16, 2014 |
| K123980 | misonix | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | March 5, 2013 |
| K122246 | celleration | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF | August 13, 2012 |
| K112782 | misonix | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | December 1, 2011 |
| K091038 | arobella medical | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | June 19, 2009 |
| K050129 | celleration | CELLERATION MIST THERAPY SYSTEM 5.1 | May 17, 2005 |
| DEN040004 | celleration | CELLERATION MIST THERAPY SYSTEM | June 25, 2004 |