# Envoy Medical Corporation

- Location (FDA's records): St. Paul, MN
- FDA decisions: 2 (2008–2010): 1 510(k) clearance and 1 original PMA approval
- Product codes: NEA (1), OAF (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ototech, Ltd.: 1 (https://510kreport.com/company/ototech)
- Corinthian Medical, Ltd.: 1 (https://510kreport.com/company/corinthian-medical)
- Walter Lorenz Surgical, Inc.: 1 (https://510kreport.com/company/walter-lorenz-surgical)

## Firms that cite its devices most
- Ototronix, LLC: 1 (https://510kreport.com/company/ototronix)

## Its most-cited devices
- K080032: Envoycem, Model 1640 (2008), cited by 1

## Recent decisions
- P090018: Esteem Totally Implantable Hearing System (Mar 17, 2010)
- K080032: Envoycem, Model 1640 (Feb 28, 2008)

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