FDA Product Code
FDA Product Code NRB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4410
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | Alliqua Biomedical, Inc. | 2016-12-22 | Special | PDF ↗ |
| K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | Celleration, Inc. | 2014-08-13 | Traditional | PDF ↗ |
| K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2014-05-16 | Traditional | PDF ↗ |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | 2013-03-05 | Special | PDF ↗ |
| K122246 | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | Celleration, Inc. | 2012-08-13 | Special | PDF ↗ |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | 2011-12-01 | Traditional | PDF ↗ |
| K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2009-06-19 | Traditional | PDF ↗ |
| K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 | Celleration, Inc. | 2005-05-17 | Traditional | PDF ↗ |
| DEN040004 | CELLERATION MIST THERAPY SYSTEM | Celleration | 2004-06-25 | Post-NSE | — |
Product code NRB · Class II · General, Plastic Surgery. Data: openFDA.