FDA Product Code SDD: Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
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.
Leading manufacturers include Distalmotion SA.
FDA 510(k) Cleared Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field Devices (Product Code SDD)
About Product Code SDD - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SDD since 2024, with 2 receiving FDA clearance (average review time: 194 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SDD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →