Wound Cleaner, Ultrasound
General, Plastic Surgery · 21 CFR 878.4410
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 MDR events
22 adverse event reports on file
- ULTRAMISTMay 4, 2026InjurySanuwave, Inc.MW5187550
- ULTRAMISTApr 30, 2026DeathSanuwave, Inc.MW5187490
- ULTRAMISTApr 30, 2026InjurySanuwave, Inc.MW5187500
- AROBELLA QOUSTIC SYSTEMMar 26, 2026InjuryArobella Medical, Llc.MW5185913
- AROBELLA ULTRAMar 26, 2026OtherArobella Medical, LlcMW5185973
- WOUND CLEANER, ULTRASOUNDJun 26, 2025InjuryArobella Medical, LlcMW5172049
- QOUSTIC WOUND THERAPY SYSTEMDec 26, 2024InjuryUnkMW5163979
- ULTRAMIST SINGLE USE APPLICATORMay 3, 2023MalfunctionDynamic Group16859928
- MIST THERAPY SYSTEMOct 22, 2010OtherCelleration, Inc.3004580659-2010-00001
- MIST THERAPY SYSTEMApr 21, 2009OtherCelleration, Inc.3004580659-2009-00002
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
Donatelle Plastics, Llc
NEW BRIGHTON, MN, US
Sanuwave, Inc.
Eden Prairie, MN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Isomedix Operations Inc.
Sandy, UT, US
Isomedix Operations, Inc.
Libertyville, IL, US
Dynamic Group
Ramsey, MN, US
Arobella Medical, Llc
Minnetonka, MN, US
Nortech Systems, Inc.
Milaca, MN, US
Misonix, Llc
Farmingdale, NY, US
Midwest Sterilization Corp.
JACKSON, MO, US
Sterigenics Us Llc
Gurnee, IL, US
510(k) clearances
9 clearances for this product code
- Alliqua Biomedical, Inc.Dec 22, 2016
K162721 · Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
- Celleration, Inc.Aug 13, 2014
K140782 · ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
- Arobella Medical, LLCMay 16, 2014
K131096 · AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
- Misonix, Inc.Mar 5, 2013
K123980 · SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
- Celleration, Inc.Aug 13, 2012
K122246 · MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
- Misonix, Inc.Dec 1, 2011
K112782 · MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
- Arobella Medical, LLCJun 19, 2009
K091038 · AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
- Celleration, Inc.May 17, 2005
K050129 · CELLERATION MIST THERAPY SYSTEM 5.1