Clearance Summary
Dynamis Robotic Surgical System received FDA 510(k) clearance under submission number K260369, sponsored by LEM Surgical AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-06-20.
- Submission: K260369
- Applicant / Sponsor: LEM Surgical AG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2026-06-20
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.