FDA device listing
3DV-190,CV-190,LTF-190-10-3D,MAJ-2053,MAJ-2054
FDA device listing 1989513390 · OLYMPUS CORPORATION
Key facts
| Proprietary names | 3DV-190,CV-190,LTF-190-10-3D,MAJ-2053,MAJ-2054 |
|---|---|
| Owner/operator | OLYMPUS CORPORATION |
| Owner/operator number | 9067818 |
| Premarket submissions | K123365 |
| Product codes | FGB, GCJ, HET, NWB |
| Device names | FGB - Ureteroscope And Accessories, Flexible/Rigid, GCJ - Laparoscope, General & Plastic Surgery, HET - Laparoscope, Gynecologic (And Accessories), NWB - Endoscope, Accessories, Narrow Band Spectrum |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 884.1720 |
| Review panels | Gastroenterology & Urology, Obstetrics/Gynecology |
| Registered establishments | AIZU OLYMPUS CO., LTD., OLYMPUS MEDICAL SYSTEMS CORP., SHIRAKAWA OLYMPUS CO., LTD. |
| Establishment registrations | 8010047, 9610595, 3002808148 |
| FEI numbers | 3002807795, 3002808148, 3002964398 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database