510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220078Unknown

Eroxon

Futura Medical Developments Limited, Guildford, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN220078 is the FDA 510(k) clearance record for Eroxon, a class II device, cleared for Futura Medical Developments Limited on under FDA product code QWW (Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.). FDA's definition for product code QWW reads: "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". FDA records list one 510(k) clearance for Futura Medical Developments Limited. As of , FDA records show no recalls naming DEN220078.

Clearance record

Decision date
Received
(231 days to decision)
Product code
QWW Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
Regulation
21 CFR 876.5021
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Futura Medical Developments Limited The Surrey Technology Centre, Guildford, GB
Third party review
No

Clearances, product code QWW

Trailing 12 months

FDA records hold no clearances under product code QWW in the trailing twelve months.

FDA records show no clearances under product code QWW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260