# Pelvalon

- Location (FDA's records): Hillsborough, CA
- FDA decisions: 2 (2015–2015): 1 510(k) clearance and 1 De Novo grant
- Names in FDA's records: Pelvalon (1); Pelvalon, Inc. (1)
- Product codes: PJH (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
- DEN140020: Eclipse System (2015), cited by 1

## Recent decisions
- K150558: Eclipse System (Nov 12, 2015)
- DEN140020: Eclipse System (Feb 12, 2015)

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