510(k) K162721
K162721 is an FDA 510(k) premarket notification submitted by Alliqua Biomedical, Inc. for the device "Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator". The FDA issued a decision of Substantially Equivalent on December 22, 2016. The device falls under product code NRB (Wound Cleaner, Ultrasound), a Class II device regulated under 21 CFR 878.4410. Alliqua Biomedical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2016
- Date Received
- September 29, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Cleaner, Ultrasound
- Device Class
- Class II
- Regulation Number
- 878.4410
- Review Panel
- SU
- Submission Type
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