Dexter L6 System
FDA 510(k) K251197 · Distalmotion SA
Submission
- Device name
- Dexter L6 System
- Applicant
- Distalmotion SA
Epalinges, CH - Received
- April 17, 2025
- Decision date
- September 30, 2025
- 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…
Other 510(k)s with product code SDD
More from Distalmotion SA
Questions and answers
When was Dexter L6 System cleared by the FDA?
Dexter L6 System (K251197) received a 510(k) decision of Substantially Equivalent on September 30, 2025, 166 days after the submission was received.
What is the product code of K251197?
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.