510(k) K260972
- Device
- OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
- Applicant
- Sony Corporation
- 510(k) number
- K260972
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-26
- Date received
- 2026-03-24
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hideaki Kawano
- Address
- 5-1-1, Minatomirai Nishi-Ku Yokohama-Shi JP 220-8750 220-8750
FDA Registration Numbers#
- 3013445147
- 3013557562
- 3005369776
- 3008383115
- 3042953929
- 3007305485
- 1061124
- 1060680
- 3001556604
- 1320468
- 3011277660
- 3010157088
- 3011063460
- 3015539532
- 3010860245
- 1032347
- 3013002341
- 1527736
- 3014579024
- 9611281
- 3010564249
- 3007695959
- 3010380518
- 8043980
- 3010437008
- 1416980
- 1225798
- 3017262662
- 1221826
- 3010806467
- 9612278
- 3014663814
- 3015231789
- 8010591
- 3007766601
- 3008386005
- 3043225236
- 1225984
- 3016527960
- 1423537
- 1720747
- 1646747
- 2244478
- 9611594
- 3017390965
- 3010684280
- 3010399422
- 3007703432
- 3006990600
- 3006897899
- 3012507533
- 3002907620
- 9616067
- 3014635169
- 3012883081
- 1055236
- 3003755939
- 3008309062
- 3009217531
- 1018470
- 3008843439
- 8010877
- 3003935342
- 3026606306
- 3000237660
- 9680837
- 1412854
- 3015219237
- 3008770252
- 3009763019
- 3013665681
- 9680001
- 2648727
- 3010601984
- 1220351
- 1054241
- 8010298
- 3003435550
- 3010806653
Source Documents#
Other 510(k) Records For Product Code GCJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |