Wound Cleaner, Ultrasound
The Ultrasound Wound Cleaner is a device that delivers a cleaning fluid to a wound pulsed using low-power ultrasound radiation, intended to clean and mildly debride wounds. The ultrasound generator delivers 1.0 mW/cm2 or less energy to the wound, keeping the energy level low for safe wound management. It is an FDA Class 2 device under 21 CFR 878.4410, requiring 510(k) clearance, and falls within the General and Plastic Surgery specialty with product code NRB. The device is eligible for third-party 510(k) review. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NRB
- Device Class
- FDA class 2
- Regulation Number
- 878.4410
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | Dec 22, 2016 | Substantially Equivalent | Alliqua Biomedical, Inc. |
| K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | Aug 13, 2014 | Substantially Equivalent | Celleration, Inc. |
| K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | May 16, 2014 | Substantially Equivalent | Arobella Medical, LLC |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Mar 05, 2013 | Substantially Equivalent | Misonix, Inc. |
| K122246 | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | Aug 13, 2012 | Substantially Equivalent | Celleration, Inc. |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Dec 01, 2011 | Substantially Equivalent | Misonix, Inc. |
| K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | Jun 19, 2009 | Substantially Equivalent | Arobella Medical, LLC |
| K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 | May 17, 2005 | Substantially Equivalent | Celleration, Inc. |
| DEN040004 | CELLERATION MIST THERAPY SYSTEM | Jun 25, 2004 | Unknown | Celleration |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.