# Syntheon, LLC

- Location (FDA's records): Miami, FL
- FDA decisions: 3 (2008–2023): 3 510(k) clearances
- Names in FDA's records: Syntheon, LLC (2); Syntheon (1)
- Product codes: PZX (2), FDF (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spirus Medical, Inc.: 1 (https://510kreport.com/company/spirus-medical)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)

## Firms that cite its devices most
- Genesee Biomedical, Inc.: 1 (https://510kreport.com/company/genesee-biomedical)

## Its most-cited devices
- K220305: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (2022), cited by 1
- K232295: LAA Exclusion System (2023), cited by 1

## Recent decisions
- K232295: LAA Exclusion System (Aug 30, 2023)
- K220305: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (Oct 28, 2022)
- K080317: Enolok-for Endoscoped with 12.8>Dia.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>Dia. 11.5MM Shaft ,Model Pel (Apr 29, 2008)

Source page: https://510kreport.com/company/syntheon