Clearance Summary
MONOFIX PDO received FDA 510(k) clearance under submission number K253879, sponsored by Samyang Holdings Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-08-25.
- Submission: K253879
- Applicant / Sponsor: Samyang Holdings Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4840
- Decision date: 2026-08-25
Classification & Regulation
This clearance is catalogued under FDA product code NEW and 21 CFR 878.4840, within the General, Plastic Surgery review panel as a Class II device.