# Rejoni, Inc.

- Location (FDA's records): Bedford, MA
- FDA decisions: 2 (2022–2026): 1 510(k) clearance and 1 original PMA approval
- Product codes: LKF (1), MCN (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
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Recent decisions
- P250051: Juveena Hydrogel System (Sep 28, 2026)
- K222798: Rejoni Intrauterine Catheter (Dec 16, 2022)

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