Not Cleared Direct

DEN130047 - PROLONG (FDA 510(k) Clearance)

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

DEN130047 · Ergon Medical , Ltd. · Gastroenterology & Urology device
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Mar 2015
Decision
487d
Days
Class 2
Risk

DEN130047 is an FDA 510(k) submission (not cleared) for the PROLONG. Classified as Vibrator For Climax Control Of Premature Ejaculation (product code PIA), Class II - Special Controls.

Submitted by Ergon Medical , Ltd. (West Sussex, GB). The FDA issued a Not Cleared (DENG) decision on March 20, 2015 after a review of 487 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5025 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 487 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ergon Medical , Ltd. devices

Submission Details

510(k) Number DEN130047 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 18, 2013
Decision Date March 20, 2015
Days to Decision 487 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
357d slower than avg
Panel avg: 130d · This submission: 487d
Pathway characteristics

Device Classification

Product Code PIA Vibrator For Climax Control Of Premature Ejaculation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5025
Definition Vibrator For Climax Control Training For The Treatment Of Premature Ejaculation.
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.