K162721 is an FDA 510(k) clearance for the Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator. This device is classified as a Wound Cleaner, Ultrasound (Class II - Special Controls, product code NRB).
Submitted by Alliqua Biomedical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 22, 2016, 84 days after receiving the submission on September 29, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4410. 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.
| 510(k) Number | K162721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 84 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NRB — Wound Cleaner, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4410 |
| 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 |