Not Cleared Post-NSE

DEN040004 - CELLERATION MIST THERAPY SYSTEM (FDA 510(k) Clearance)

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

DEN040004 · Celleration · General & Plastic Surgery device
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Jun 2004
Decision
57d
Days
Class 2
Risk

DEN040004 is an FDA 510(k) submission (not cleared) for the CELLERATION MIST THERAPY SYSTEM. Classified as Wound Cleaner, Ultrasound (product code NRB), Class II - Special Controls.

Submitted by Celleration (Eden Prairie, US). The FDA issued a Not Cleared (DENG) decision on June 25, 2004 after a review of 57 days.

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. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Celleration devices

Submission Details

510(k) Number DEN040004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 29, 2004
Decision Date June 25, 2004
Days to Decision 57 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 114d · This submission: 57d
Pathway characteristics

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.