510(k) K193026
- Device
- Visera Elite II Video System Center, Visera Elite II Endoeye 3D
- Applicant
- Olympus Medical Systems Corp.
- 510(k) number
- K193026
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-03
- Date received
- 2019-10-30
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Toshiyuki Nakajima
- Address
- 2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507
FDA Registration Numbers#
- 1123137
- 1222997
- 3011459664
- 3009057691
- 2245304
- 3004215117
- 3025306172
- 8010047
- 1060680
- 3031238646
- 3032391
- 8010510
- 3010041511
- 1923569
- 3012460907
- 3010432890
- 3038187466
- 3008729892
- 3006990600
- 9613793
- 3010177712
- 3009420598
- 3011936016
- 3015173212
- 3015453963
- 3014611142
- 2030624
- 8010026
- 3027339877
- 2183319
- 3001722928
- 3004142400
- 3042225166
- 3009039068
- 9680001
- 3015241782
- 3010547268
- 9680515
- 1225984
- 9680952
- 9611612
- 3016248634
- 9611281
- 3001675293
- 2529846
- 3007791595
- 3003755939
- 1820334
- 3003915875
- 1219930
- 3011221476
- 3004526608
- 9616567
- 1528319
- 2210968
- 3008864603
- 3005012805
- 3030839824
- 3013476721
- 3013557562
- 3020468145
- 1416980
- 3043225236
- 3031594238
- 3002579136
- 3014202166
- 3007137643
- 3004044817
- 1417592
- 3021875817
- 3008386005
- 1317547
- 3014644276
- 3014991167
- 3043152784
- 3035366890
- 3002259632
- 3008044552
- 3010220244
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2026-01-13 |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 |
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