NRB · Wound Cleaner, Ultrasound
General, Plastic Surgery · 21 CFR 878.4410 · Class 2
Overview
| Product Code | NRB |
|---|---|
| Device Name | Wound Cleaner, Ultrasound |
| Regulation | 21 CFR 878.4410 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | Alliqua Biomedical, Inc. | Dec 22, 2016 | SESE |
| K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | Celleration, Inc. | Aug 13, 2014 | SESE |
| K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | Arobella Medical, LLC | May 16, 2014 | SESE |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | Mar 5, 2013 | SESE |
| K122246 | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | Celleration, Inc. | Aug 13, 2012 | SESE |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | Dec 1, 2011 | SESE |
| K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | Arobella Medical, LLC | Jun 19, 2009 | SESE |
| K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 | Celleration, Inc. | May 17, 2005 | SESE |
| DEN040004 | CELLERATION MIST THERAPY SYSTEM | Celleration | Jun 25, 2004 | DENG |
Top Applicants
- Celleration, Inc. — 3 clearances
- Misonix, Inc. — 2 clearances
- Arobella Medical, LLC — 2 clearances
- Celleration — 1 clearance
- Alliqua Biomedical, Inc. — 1 clearance
