SDD — Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field Class II

FDA Device Classification

Classification Details

Product Code
SDD
Device Class
Class II
Regulation Number
878.4965
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251197distalmotionDexter L6 SystemSeptember 30, 2025
K250435distalmotionDexter L6 SystemMay 27, 2025
DEN230084distalmotionDexter L6 SystemOctober 25, 2024