# K260653: Dexter L6 System

- Pathway: 510(k) (Traditional)
- Applicant: Distalmotion SA
- Decided: Jun 11, 2026 after 104 days
- Product code: SDD (Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field)
- Device class: 2
- Regulation: 21 CFR 878.4965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN230084 (2024). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251197: Dexter L6 System, Distalmotion SA (2025) Summary page 5.

## Indications for use
The Distalmotion Dexter L6 System is intended to assist in the accurate control of endoscopes as well as endoscopic instruments for endoscopic manipulation of tissue, including grasping, suturing, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair, cholecystectomy, total benign hysterectomy including salpingo-oophorectomy, and sacrocolpopexy. The system is indicated for adult use, defined as 22 years old and older. It is intended for use by trained laparoscopic or robotic surgeons in an operating room environment in accordance with the representative and specific procedures set forth in the Instructions for Use.

Source page: https://510kreport.com/device/K260653
Methodology: https://510kreport.com/methodology