# Fulwell, LLC

- Location (FDA's records): Miami, FL
- FDA decisions: 2 (2019–2020): 2 510(k) clearances
- Product codes: GEI (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 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
- Valleylab, Inc.: 1 (https://510kreport.com/company/valleylab)
- Ellman Intl., Inc.: 1 (https://510kreport.com/company/ellman-intl)

## Recent decisions
- K200931: RF Surgical Generator (Nov 24, 2020)
- K183564: Electrosurgical Generator (Jun 13, 2019)

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