# DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260115 |
| Device | DRIM-Nail System |
| Applicant | 41Medical AG |
| Specialty / panel | Other |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-14 |
| Decision date | 2026-09-11 |
| Review time (days) | 240 |
| Third-party review | No |
| Applicant location | Bettlach, CH |

## Why this score
- 240-day review, longer than typical.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260115). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.