DRIM-Nail System— 510(k) K260115
Substantially Equivalent41Medical AG
FDA 510(k) clearance K260115 for DRIM-Nail System, Substantially Equivalent on 2026-09-11. Applicant: 41Medical AG.
Summary
The DRIM-Nail System from 41Medical comes with thin record data. There's no product code, and the advisory panel field reads Unknown. Without a product code, the class and regulation can't be filled in either. The record doesn't describe what the nail system is for.
It was a Traditional 510(k), reviewed by the Orthopedic panel and decided Substantially Equivalent.
41Medical filed from Bettlach, Switzerland. Review took 240 days (January 14 to September 11, 2026).
Clearance details
- Applicant
- 41Medical AG
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bettlach, CH
Data sourced from openFDA. This site is unofficial and independent of the FDA.