Roen Surgical, Inc. is one of 417 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Roen Surgical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Zamenix™ P
1
Total
1
Cleared
0
Denied
Roen Surgical, Inc. has 1 FDA 510(k) cleared medical devices. Based in Daejeon, KR.
Latest FDA clearance: Aug 2026. Active since 2026. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Roen Surgical, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Secure BioMed Evaluations as regulatory consultant.
FDA 510(k) Regulatory Record - Roen Surgical, Inc.
1 devices