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SDDClass II

Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

21 CFR 878.4965 / General, Plastic Surgery
FDA source (opens on fda.gov)

SDD is the FDA product code for Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field, a class II device type, regulated under 21 CFR 878.4965. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SDD
Device name
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
FDA 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.
Regulation
21 CFR 878.4965
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code SDD

By decision year
5 clearances under product code SDD with a decision year between 2024 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SDD by decision year
YearClearances
20241
20252
20262

Applicants with the most clearances

Product code SDD
Applicants holding the most 510(k) clearances under product code SDD
ApplicantClearances
Distalmotion SA5

Companies listing this code with FDA

Companies whose registered establishments list this code