Clearance Summary
DRIM-Nail System received FDA 510(k) clearance under submission number K260115, sponsored by 41Medical AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-09-11.
- Submission: K260115
- Applicant / Sponsor: 41Medical AG
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2026-09-11
Classification & Regulation
This clearance is catalogued under FDA product code , within the Unknown review panel as a device.