# S4 Medical Corp.

- Location (FDA's records): Chagrin Falls, OH
- FDA decisions: 2 (2023–2024): 1 510(k) clearance and 1 De Novo grant
- Product codes: QXU (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN230006: esolution (2023), cited by 1

## Recent decisions
- K243233: esolution® Esophageal Retractor (Nov 9, 2024)
- DEN230006: esolution (Sep 6, 2023)

Source page: https://510kreport.com/company/s4-medical