# DEN220078: Eroxon

- Pathway: De Novo (Direct)
- Applicant: Futura Medical Developments Limited
- Decided: Jun 9, 2023 after 231 days
- Product code: QWW (Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.)
- Device class: 2
- Regulation: 21 CFR 876.5021
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Treatment of erectile dysfunction in adult males aged 22 years and over.

Source page: https://510kreport.com/device/DEN220078
Methodology: https://510kreport.com/methodology