Not Cleared Direct

DEN220078 - Eroxon (FDA 510(k) Clearance)

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

DEN220078 · Futura Medical Developments Limited · Gastroenterology & Urology device
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Jun 2023
Decision
231d
Days
Class 2
Risk

DEN220078 is an FDA 510(k) submission (not cleared) for the Eroxon. Classified as Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction. (product code QWW), Class II - Special Controls.

Submitted by Futura Medical Developments Limited (Guildford, GB). The FDA issued a Not Cleared (DENG) decision on June 9, 2023 after a review of 231 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5021 - 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 DEN220078 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 21, 2022
Decision Date June 09, 2023
Days to Decision 231 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
101d slower than avg
Panel avg: 130d · This submission: 231d
Pathway characteristics

Device Classification

Product Code QWW Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5021
Definition A Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction Is A Device That Is Applied On The Penis And Stimulates The Nerve Endings By Inducing A Temperature Change, Leading To Tumescence And Erection.
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.