DEN220078 is an FDA 510(k) submission for the Eroxon. This device is classified as a Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction. (Class II - Special Controls, product code QWW).
Submitted by Futura Medical Developments Limited (Guildford, GB). The FDA issued a Not Cleared (DENG) decision on June 9, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5021. 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..
| 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 | - |
| Product Code | QWW - Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction. |
| Device Class | Class II - 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. |