Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12
FDA 510(k) K122246 · Celleration, Inc.
510(k) numberK122246
Submission
- Device name
- Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12
- Applicant
- Celleration, Inc.
Eden Prairie, MN, US - Received
- July 27, 2012
- Decision date
- August 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorNRB · Special | Alliqua Biomedical, Inc. | 12/22/2016SE |
| 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 |
| 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 |
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Questions and answers
When was Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12 cleared by the FDA?
Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12 (K122246) received a 510(k) decision of Substantially Equivalent on August 13, 2012, 17 days after the submission was received.
What is the product code of K122246?
The FDA product code is NRB – Wound Cleaner, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 878.4410.