Product code NRB
- Device name
- Wound Cleaner, Ultrasound
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4410
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | Alliqua Biomedical, Inc. | 2016-12-22 |
| K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | Celleration, Inc. | 2014-08-13 |
| K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2014-05-16 |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | 2013-03-05 |
| K122246 | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | Celleration, Inc. | 2012-08-13 |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | 2011-12-01 |
| K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2009-06-19 |
| K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 | Celleration, Inc. | 2005-05-17 |
| DEN040004 | CELLERATION MIST THERAPY SYSTEM | Celleration | 2004-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812265010317 | UltraMIST Generator | SANUWAVE Health, Inc. | 2021-01-25 |
| 00812265010324 | UltraMIST Treatment Wand | SANUWAVE Health, Inc. | 2021-01-25 |
| 00812265010331 | UltraMIST Single Use Applicator | SANUWAVE Health, Inc. | 2021-01-25 |
| 00812265010348 | UltraMIST Single Use Applicator (12 Pack) | SANUWAVE Health, Inc. | 2021-01-25 |
| 00853077002060 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002220 | Qoustic Wound Therapy System® Ultrasonic Generator | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002213 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002176 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002169 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002152 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002145 | Qoustic Choice® Wound Therapy System Converter Hand Piece | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002138 | Qoustic Choice® Wound Therapy System, Model AR1000D Series | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002121 | Qoustic Wound Therapy System® Qoustic Key® | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002114 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002107 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002091 | Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002077 | Qoustic Wound Therapy System®, Model AR1000B Series | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002039 | Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002022 | Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002015 | Qoustic Wound Therapy System® Converter Hand Piece | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002008 | Qoustic Wound Therapy System®, Model AR1000 Series | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002237 | Qoustic Wound Therapy System® Ultrasonic Generator | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002244 | Qoustic Choice® Wound Therapy System Ultrasonic Generator | AROBELLA MEDICAL, LLC | 2017-03-01 |
| 00853077002183 | Qoustic Choice® Wound Therapy System, Disposable Tubing Set | AROBELLA MEDICAL, LLC | 2017-01-20 |
| 10853077002203 | Qoustic Choice® Wound Therapy System, Disposable Tubing Set | AROBELLA MEDICAL, LLC | 2017-01-20 |
| 10816789010201 | UltraMIST Treatment Wand | ALLIQUA BIOMEDICAL, INC. | 2016-09-07 |
| 00816789010204 | UltraMIST Treatment Wand | ALLIQUA BIOMEDICAL, INC. | 2016-09-07 |
| 00816789010259 | MIST Therapy Applicator | ALLIQUA BIOMEDICAL, INC. | 2016-09-07 |
| 00816789010242 | MIST 360 Applicator | ALLIQUA BIOMEDICAL, INC. | 2016-09-07 |
| 00816789010235 | UltraMIST Applicator | ALLIQUA BIOMEDICAL, INC. | 2016-09-07 |