Not Cleared Direct

DEN150011 - Sonablate 450 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150011 · Sonacare Medical, LLC · Gastroenterology & Urology device
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Oct 2015
Decision
200d
Days
Class 2
Risk

DEN150011 is an FDA 510(k) submission (not cleared) for the Sonablate 450. Classified as High Intensity Ultrasound System For Prostate Tissue Ablation (product code PLP), Class II - Special Controls.

Submitted by Sonacare Medical, LLC (Charlotte, US). The FDA issued a Not Cleared (DENG) decision on October 9, 2015 after a review of 200 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4340 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework.

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Submission Details

510(k) Number DEN150011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 23, 2015
Decision Date October 09, 2015
Days to Decision 200 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 130d · This submission: 200d
Pathway characteristics

Device Classification

Product Code PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4340
Definition Prostate Tissue Ablation
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 Gastroenterology & Urology devices follow this clearance model.