SDD — Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field Class II
FDA product code SDD covers "Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field", a Class II medical device regulated under 21 CFR 878.4965. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
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.