Dexter L6 System
FDA 510(k) clearance K251197 · decided 2025-09-30
Clearance details
- K-number
- K251197
- Device name
- Dexter L6 System
- Applicant
- Distalmotion SA
- Decision
- Substantially Equivalent
- Date received
- 2025-04-17
- Decision date
- 2025-09-30
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- SDD
- Device class
- 2
- Regulation number
- 878.4965
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Epalinges, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dexter L6 System (K260653) | Distalmotion SA | 2026-06-11 |
| Dexter L6 System (K250435) | Distalmotion SA | 2025-05-27 |
| Dexter L6 System (DEN230084) | Distalmotion SA | 2024-10-25 |
Recalls involving this device
No recalls on record reference this clearance.