Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
FDA 510(k) K162721 · Alliqua Biomedical, Inc.
510(k) numberK162721
Submission
- Device name
- Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
- Applicant
- Alliqua Biomedical, Inc.
Eden Prairie, MN, US - Received
- September 29, 2016
- Decision date
- December 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRB – Wound Cleaner, Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4410
- Specialty
- General, Plastic Surgery
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
Other 510(k)s with product code NRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140782 | Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist ApplicatorNRB · Traditional | Celleration, Inc. | 08/13/2014SE |
| K131096 | AR1000 Series Ultrasonic Wound Therapy SystemNRB · Traditional | Arobella Medical, LLC | 05/16/2014SE |
| K123980 | Sonicone Plus Ultrasound Wound Care System and AccessoriesNRB · Special | Misonix, Inc. | 03/05/2013SE |
| K122246 | Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12NRB · Special | Celleration, Inc. | 08/13/2012SE |
| K112782 | Misonix Sonicone(R) Ultrasonic Wound Care System and AccessoriesNRB · Traditional | Misonix, Inc. | 12/01/2011SE |
| K091038 | AS 1000 Ultrasound Wound Therapy SystemNRB · Traditional | Arobella Medical, LLC | 06/19/2009SE |
| K050129 | Celleration Mist Therapy System 5.1NRB · Traditional | Celleration, Inc. | 05/17/2005SE |
More from Celleration, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171041 | SilverSealFRO · Traditional | 08/22/2017SE |
Questions and answers
When was Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator cleared by the FDA?
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator (K162721) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 84 days after the submission was received.
What is the product code of K162721?
The FDA product code is NRB – Wound Cleaner, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 878.4410.