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#
- 3010187826
- 1418975
- 8010312
- 3048053025
- 3014925413
- 3012470322
- 3030446844
- 1718873
- 3015225571
- 3007842664
- 3010594949
- 3005695724
- 3014262693
- 3010131466
- 3015540957
- 3012818475
- 3007648309
- 1526534
- 3010400367
- 1000122786
- 3001124136
- 3004464325
- 1030489
- 3013886523
- 9611503
- 2183870
- 3008868758
- 3030645016
- 1030451
- 8010177
- 3002807090
- 3043532708
- 2433012
- 3008816935
- 3008791915
- 3016555232
- 3016727307
- 3043226252
- 1418479
- 2219920
- 3048141561
- 9617070
- 3011307265
- 3017405993
- 3016050940
- 3014579024
- 3015453963
- 2182318
- 1220477
- 3013376016
- 2182269
- 3004598644
- 3004111573
- 3012497308
- 3012447612
- 8043746
- 3009513193
- 2182799
- 2028523
- 3011782009
- 3015153469
- 3016087306
- 3013505983
- 3016076698
- 3030153385
- 1828288
- 3007456622
- 3011559089
- 2648666
- 1223422
- 1724474
- 3029895042
- 2087572
- 3004483538
- 2133810
- 8010418
- 1421879
- 1825146
- 3022320321
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262397 | CuratOR EX2742 | Eizo Corporation | 2026-09-11 |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026-09-01 |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | 2026-08-26 |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | 2026-08-13 |
| 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 |
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