QWW · Class II · 21 CFR 876.5021

FDA Product Code QWW: Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction.

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.

Leading manufacturers include Futura Medical Developments Limited.

1
Total
0
Cleared
231d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction. Devices (Product Code QWW)

1 devices
1–1 of 1
Not Cleared Jun 09, 2023
Eroxon
DEN220078
Futura Medical Developments Limited
Gastroenterology & Urology · 231d

About Product Code QWW - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWW since 2023, with 0 receiving FDA clearance (average review time: 231 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QWW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →