Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
An electromechanical surgical system wherein both the surgeon and the user interface can be in the sterile field is a software-controlled electromechanical platform with fully positionable patient/device interfaces for minimally invasive surgical procedures, uniquely allowing both the surgeon and the primary control interface to transiently have sterile field presence as needed for the clinical context of use. It is classified as FDA Class II (510(k) required) under regulation 878.4965 in the General and Plastic Surgery specialty, with product code SDD. The device is not an implant and does not support life-sustaining functions.
Research product code SDD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- SDD
- Device Class
- FDA class 2
- Regulation Number
- 878.4965
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260653 | Dexter L6 System | Jun 11, 2026 | Substantially Equivalent | Distalmotion SA |
| K251197 | Dexter L6 System | Sep 30, 2025 | Substantially Equivalent | Distalmotion SA |
| K250435 | Dexter L6 System | May 27, 2025 | Substantially Equivalent | Distalmotion SA |
| DEN230084 | Dexter L6 System | Oct 25, 2024 | Unknown | Distalmotion SA |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.