Not Cleared Direct Expedited

DEN140020 - ECLIPSE SYSTEM (FDA 510(k) Clearance)

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

DEN140020 · Pelvalon · Gastroenterology & Urology device
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Feb 2015
Decision
233d
Days
Class 2
Risk

DEN140020 is an FDA 510(k) submission (not cleared) for the ECLIPSE SYSTEM. Classified as Dynamic Rectal Control System (product code PJH), Class II - Special Controls.

Submitted by Pelvalon (Hillsborough, US). The FDA issued a Not Cleared (DENG) decision on February 12, 2015 after a review of 233 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5930 - 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.

View all Pelvalon devices

Submission Details

510(k) Number DEN140020 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 24, 2014
Decision Date February 12, 2015
Days to Decision 233 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
103d slower than avg
Panel avg: 130d · This submission: 233d
Pathway characteristics

Device Classification

Product Code PJH Dynamic Rectal Control System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5930
Definition Intended To Treat Fecal Incontinence By Controlling The Size Of The Rectal Lumen.
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.