FDA product code SDD: Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
SDD is the FDA product code for electromechanical surgical system wherein the surgeon annd the user interface can be in the sterile field. It is a Class II device, regulated under 21 CFR 878.4965 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under SDD, 4 in the last five years. The average 510(k) review took 119 days (median 104); 119 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field |
| Device class | Class II |
| Regulation | 21 CFR 878.4965 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SDD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 134 |
| 2026 | 2 | 104 |
Compare with all 510(k) review times · Search every SDD clearance
Top SDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Distalmotion SA | 4 | 2026-08-11 |
Most recent SDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261398 | Distalmotion SA | Dexter L6 System | 2026-08-11 | 104 |
| K260653 | Distalmotion SA | Dexter L6 System | 2026-06-11 | 104 |
| K251197 | Distalmotion SA | Dexter L6 System | 2025-09-30 | 166 |
| K250435 | Distalmotion SA | Dexter L6 System | 2025-05-27 | 102 |
Recalls for SDD devices
openFDA lists no recalls for product code SDD.
Frequently asked questions
What is FDA product code SDD?
SDD is the FDA product code for electromechanical surgical system wherein the surgeon annd the user interface can be in the sterile field. It is a Class II device, regulated under 21 CFR 878.4965 and reviewed by the General and Plastic Surgery panel.
What device class is SDD?
Class II, regulation 21 CFR 878.4965. Typical premarket route: 510(k).
How long does a 510(k) take for product code SDD?
Across 4 cleared submissions the average was 119 days from receipt to decision (median 104).
Which companies have the most SDD clearances?
Distalmotion SA (4).
Next steps
- Run an FDA pathway report with predicate devices for product code SDD
- Run a recall and safety report across every SDD manufacturer
- Watch product code SDD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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