FDA device listing
Video Colonoscope EC-760R-V/L,Video Colonoscope EC-760ZP-V/L,Video Gastroscope EG-760R,Video Gastroscope EG-760Z,Water…
FDA device listing 1981123637 · FUJIFILM CORPORATION
Key facts
| Proprietary names | Video Colonoscope EC-760R-V/L,Video Colonoscope EC-760ZP-V/L,Video Gastroscope EG-760R,Video Gastroscope EG-760Z,Water Tank WT-603 |
|---|---|
| Owner/operator | FUJIFILM CORPORATION |
| Owner/operator number | 8031568 |
| Premarket submissions | K172916 |
| Product codes | FDF, FDS |
| Device names | FDF - Colonoscope And Accessories, Flexible/Rigid, FDS - Gastroscope And Accessories, Flexible/Rigid |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | FUJIFILM Corporation Medical Systems Research & Development Center Kaisei, FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office, FUJIFILM Healthcare Manufacturing Corporation Sano Office |
| Establishment registrations | 3003775006, 3006161756, 3042225166 |
| FEI numbers | 3002808127, 3003775006, 3042225166 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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