FDA product code NRB: Wound Cleaner, Ultrasound
NRB is the FDA product code for wound cleaner, ultrasound. It is a Class II device, regulated under 21 CFR 878.4410 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under NRB, from 4 different applicants. The average 510(k) review took 119 days (median 76). 1 De Novo request was granted under it.
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
Classification
| Field | Value |
|---|---|
| Device name | Wound Cleaner, Ultrasound |
| Device class | Class II |
| Regulation | 21 CFR 878.4410 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NRB clearance
Top NRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Celleration, Inc. | 3 | 2014-08-13 |
| Arobella Medical, LLC | 2 | 2014-05-16 |
| Misonix, Inc. | 2 | 2013-03-05 |
| Alliqua Biomedical, Inc. | 1 | 2016-12-22 |
Most recent NRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162721 | Alliqua Biomedical, Inc. | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | 2016-12-22 | 84 |
| K140782 | Celleration, Inc. | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | 2014-08-13 | 135 |
| K131096 | Arobella Medical, LLC | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | 2014-05-16 | 393 |
| K123980 | Misonix, Inc. | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | 2013-03-05 | 69 |
| K122246 | Celleration, Inc. | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | 2012-08-13 | 17 |
Recalls for NRB devices
openFDA lists no recalls for product code NRB.
Frequently asked questions
What is FDA product code NRB?
NRB is the FDA product code for wound cleaner, ultrasound. It is a Class II device, regulated under 21 CFR 878.4410 and reviewed by the General and Plastic Surgery panel.
What device class is NRB?
Class II, regulation 21 CFR 878.4410. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRB?
Across 8 cleared submissions the average was 119 days from receipt to decision (median 76).
Which companies have the most NRB clearances?
Celleration, Inc. (3); Arobella Medical, LLC (2); Misonix, Inc. (2); Alliqua Biomedical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRB
- Run a recall and safety report across every NRB manufacturer
- Watch product code NRB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times