# Promepal Sam

- Location (FDA's records): Monaco, MC
- FDA decisions: 1 (2020–2020): 1 510(k) clearance
- Product codes: EYB (1)
- Predicates its devices cite: 1 (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
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)

## Recent decisions
- K192183: RocaTub Ureteral Catheter (Apr 23, 2020)

Source page: https://510kreport.com/company/promepal-sam