K250435
- 510(k) number
- K250435
- Device name
- Dexter L6 System
- Applicant
- Distalmotion SA CH
- Product code
- SDD — Electromechanical Surgical System Wherein The Surgeo
- Decision date
- 2025-05-27
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250435.pdf
Official FDA record: K250435
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.