QWW — Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. Class II
FDA product code QWW covers "Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.", a Class II medical device regulated under 21 CFR 876.5021. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWW
- Device Class
- Class II
- Regulation Number
- 876.5021
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220078 | futura medical developments limited | Eroxon | June 9, 2023 |