FDA 510(k) ClearanceGCJ
3D Laparoscope
FDA 510(k) K252697 · Guangdong Optomedic Technologies, Inc.
Clearance details
Ask AI- 510(k) number
- K252697
- Device name
- 3D Laparoscope
- Applicant
- Guangdong Optomedic Technologies, Inc.
- Product code
- GCJ
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 876.1500
- Advisory committee
- SU
- Medical specialty
- Gastroenterology, Urology
Candidate predicate devices
Ask AIOther devices cleared under product code GCJ form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262397 | CuratOR EX2742 | Eizo Corporation | |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | |
| 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 | |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | |
| 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. | |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. |
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