# DEN230084: Dexter L6 System

- Pathway: De Novo (Direct)
- Applicant: Distalmotion SA
- Decided: Oct 25, 2024 after 315 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K251197: Dexter L6 System (2025), 2 descendants of its own
- K261398: Dexter L6 System (2026), 0 descendants of its own
- K260653: Dexter L6 System (2026), 0 descendants of its own
- K250435: Dexter L6 System (2025), 0 descendants of its own

## 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, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair. The system is indicated for adult uses, as defined as 22 years old and older. It is intended for use by trained laparoscopic surgeons in an operating room environment in accordance with the representative and specific procedures set forth in the Instructions for Use. The Dexter L6 System is for prescription use only.

Source page: https://510kreport.com/device/DEN230084
Methodology: https://510kreport.com/methodology