510(k) K251197
K251197 is an FDA 510(k) premarket notification submitted by Distalmotion SA for the device "Dexter L6 System". The FDA issued a decision of Substantially Equivalent on Sep 30, 2025. The device falls under product code SDD (Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field), a Class II device regulated under 21 CFR 878.4965. Distalmotion SA has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2025
- Date Received
- Apr 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
- Device Class
- Class II
- Regulation Number
- 878.4965
- Review Panel
- SU
- Submission Type
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 to have presence inside the sterile field as needed within the clinical context of use.