510(k) K260115
K260115 is an FDA 510(k) premarket notification submitted by 41Medical AG for the device "DRIM-Nail System". The FDA issued a decision of Substantially Equivalent on Sep 11, 2026.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 2026
- Date Received
- Jan 14, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No