Dexter L6 System
FDA 510(k) K261398 · Distalmotion SA
Submission
- Device name
- Dexter L6 System
- Applicant
- Distalmotion SA
Epalinges, CH - Received
- April 29, 2026
- Decision date
- August 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SDD – Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4965
- Specialty
- General, Plastic Surgery
An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface…
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Questions and answers
When was Dexter L6 System cleared by the FDA?
Dexter L6 System (K261398) received a 510(k) decision of Substantially Equivalent on August 11, 2026, 104 days after the submission was received.
What is the product code of K261398?
The FDA product code is SDD – Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field, a Class II (moderate risk) device regulated under 21 CFR 878.4965.