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510(k) K191878

Device
DEX Device
Applicant
Dex Surgical
510(k) number
K191878
Product code
GCJ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-29
Date received
2019-07-15
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Guillaume Noury
Address
3 Rue Des Petits Ruisseaux Verrieres Le Buisson FR 91370 91370

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging SystemIntuitive Surgical, Inc.2026-10-14
K262397CuratOR EX2742Eizo Corporation2026-09-11
K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG2026-09-01
K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation2026-08-26
K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC2026-08-13
K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact2026-07-24
K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc2026-07-17
K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.2026-07-14
K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.2026-06-11
K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.2026-06-10
K253994TroKit Laparoscope Lens WiperTroCare, LLC2026-06-04
K252532Inno-Port Disposable Bladed TrocarTaiwan Surgical Corporation2026-06-02
K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.2026-05-26
K260183MediBot Needle Driver UnoParallel Robotics, LLC2026-05-24
K252985LaportSejong Medical Co., Ltd.2026-05-19

Legacy Summary#

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FDA Review#

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