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#
- 3004044817
- 3014279513
- 3007029079
- 3007185216
- 3021477808
- 8040537
- 3021519357
- 3007710878
- 3008720584
- 3015806723
- 3006716777
- 1526534
- 9680721
- 3010402752
- 3015460875
- 3013858269
- 3013557681
- 3008849319
- 9613563
- 3010380518
- 3005809810
- 3030626857
- 3011120183
- 3033715699
- 3010377594
- 3007748817
- 3009486890
- 3007583504
- 3007024186
- 3013652305
- 2087572
- 3007960282
- 3012606445
- 1211998
- 8043746
- 3010202439
- 3013551587
- 3036803067
- 3002250546
- 3006849754
- 3010621964
- 3011586151
- 1063285
- 3004837686
- 8010047
- 3004483538
- 3007305485
- 1123137
- 3012497308
- 3013886523
- 9611612
- 9611112
- 3014579161
- 3008114965
- 3010155648
- 9610617
- 3014262693
- 3007535734
- 3016851379
- 3008889904
- 3027645761
- 2020394
- 3012204368
- 3009513193
- 1054811
- 3011987935
- 3006555617
- 3011944170
- 2184009
- 2435119
- 3010188783
- 3013875599
- 1221826
- 3007748793
- 3017196117
- 3015192261
- 9680340
- 1060680
- 3009555600
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-02-24 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2026-02-18 |
| K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | 2026-02-12 |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 2026-01-23 |
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