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#
- 1926681
- 9614434
- 3014461810
- 3006716777
- 3007748793
- 3027339877
- 3007029079
- 3015539532
- 3027339887
- 1720747
- 3003418325
- 3011625895
- 3017210488
- 1720929
- 8010298
- 1718850
- 3009763019
- 3006059917
- 3013188547
- 3007712511
- 3016813690
- 3033524168
- 8010591
- 3010226575
- 3044156918
- 3015895145
- 3010305275
- 3010288205
- 3013111980
- 3010816547
- 8030967
- 3010173425
- 3013438730
- 9617070
- 1222780
- 9680357
- 3010356635
- 3004754983
- 2031093
- 3013077751
- 3010621964
- 3014982808
- 3038675429
- 1018233
- 3035642068
- 1060680
- 3009423112
- 3009183442
- 3009609358
- 3006498370
- 3006696607
- 8010877
- 2183785
- 3012510750
- 8010890
- 3012606445
- 3008132398
- 3015515531
- 3009513193
- 9616666
- 1225492
- 2648623
- 1211998
- 3009905888
- 3031240334
- 3015506965
- 3031571464
- 3030412764
- 3004111573
- 3028977843
- 3011879048
- 2183715
- 3015779311
- 3015449142
- 3015540957
- 2648666
- 3012616488
- 3005334138
- 3012995405
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | 2026-07-24 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 |
| K260710 | FloShield 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 System | Tech-Image CO., LTD. | 2026-06-10 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases