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510(k) Data Aggregation
K Number
K191878Device Name
DEX Device
Manufacturer
Date Cleared
2021-01-29
(564 days)
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Dex Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DEX device laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, suturing, transection and electro-cauterization of tissues.
Device Description
The DEX Device consists of an electro-mechanical system designed for surgeon to perform minimal invasive surgeries: laparoscopic surgery. The surgeon will use the system in a similar way than any laparoscopic instruments and remains in contact with the patient. The surgeon will positioned himself like in any classic laparoscopic procedure, standing in the sterile field close to the patient: Same installation, trocars, endoscopic camera, suction, ESU for monopolar, needles, operating table, instruments, procedure. The device consists of a Control handle and different Arms (instruments); and accessories. The Console hosts the software and the power unit. The control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. The control handle has command buttons that activate the different degrees of freedom or the Arm. Different arms can be connected on the control handle. Arms consists in a distal articulation that allows the tip (scissors, needle holder, forceps or Hook) to tilt, rotate and open-close. The arms and the control handle are reusable and autoclavable. The scissors, the dissector (Maryland) and the hook supports electrocautery monopolar energy after connecting the standard monopolar cable between DEX device and an ESU compliant with IEC 60601-2-2; After installed the neutral electrode; The user can control the cautery effect by pressing on the foot pedal switch provided with the ESU. Associated acessories includes : sleeves
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