FDA device listing
Insight-I,Insight-One
FDA device listing 2072358274 · MEDIANA CO., LTD.
Key facts
| Proprietary names | Insight-I,Insight-One |
|---|---|
| Owner/operator | MEDIANA CO., LTD. |
| Owner/operator number | 9048468 |
| Product codes | FWF |
| Device names | FWF - Camera, Television, Endoscopic, Without Audio |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4160 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MEDIANA CO., LTD. |
| Establishment registrations | 3003591740 |
| FEI numbers | 3003591740 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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