DeviceClearance

Product code QWW— Gastroenterology, Urology

Eroxon

Classification name
Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
Device class
Class 2
Regulation
21 CFR 876.5021
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QWW under 21 CFR 876.5021, via openFDA

Market context for product code QWW

FDA has cleared 1 device under product code QWW, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QWW

Recent clearances under product code QWW

Data sourced from openFDA. This site is unofficial and independent of the FDA.