Cleared Special

K162721 - Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162721 · Alliqua Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
84d
Days
Class 2
Risk

K162721 is an FDA 510(k) clearance for the Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applic.... Classified as Wound Cleaner, Ultrasound (product code NRB), Class II - Special Controls.

Submitted by Alliqua Biomedical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4410 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alliqua Biomedical, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 114d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NRB Wound Cleaner, Ultrasound
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.