# Roen Surgical, Inc.

- Location (FDA's records): Daejeon, KR
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: FGB (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
- Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi: 1 (https://510kreport.com/company/elmed-elektronik-ve-medikal-sanayi-ve-ticaret-anonim-sirketi)

## Recent decisions
- K253505: Zamenix™ P (Aug 7, 2026)

Source page: https://510kreport.com/company/roen-surgical