Product code SDD— General, Plastic Surgery

“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.”

FDA has cleared 5 devices under product code SDD between 2024 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20262 clearances
• 20252 clearances
• 20241 clearance

• Distalmotion SA5 clearances

• K261398 — Dexter L6 SystemDistalmotion SA·2026-08-11
• K260653 — Dexter L6 SystemDistalmotion SA·2026-06-11
• K251197 — Dexter L6 SystemDistalmotion SA·2025-09-30
• K250435 — Dexter L6 SystemDistalmotion SA·2025-05-27
• DEN230084 — Dexter L6 SystemDistalmotion SA·2024-10-25