Dexter L6 System— 510(k) K261398
Substantially EquivalentDistalmotion SA
FDA 510(k) clearance K261398 for Dexter L6 System, Substantially Equivalent on 2026-08-11. Applicant: Distalmotion SA. Device class: 2.
Summary
Distalmotion's Dexter L6 System is filed under product code SDD, electromechanical surgical systems where the surgeon and the user interface can be in the sterile field. The record doesn't say what L6 refers to.
Class II, 21 CFR 878.4965. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Distalmotion filed from Epalinges, Switzerland. The decision came 104 calendar days after FDA received it (April 29 to August 11, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Distalmotion SA
- Product code
- Product code SDD
- Device class
- Class 2
- Regulation
- 21 CFR 878.4965
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Epalinges, CH
Recent devices under product code SDD
view allData sourced from openFDA. This site is unofficial and independent of the FDA.