FDA device listing
PBD-1030-0707,PBD-1030-0709,PBD-1030-0712,PBD-1030-0715,PBD-1030-1007,PBD-1030-1009,PBD-1030-1012,PBD-1030-1015
FDA device listing 1143511490 · OLYMPUS CORPORATION
Key facts
| Proprietary names | PBD-1030-0707,PBD-1030-0709,PBD-1030-0712,PBD-1030-0715,PBD-1030-1007,PBD-1030-1009,PBD-1030-1012,PBD-1030-1015 |
|---|---|
| Owner/operator | OLYMPUS CORPORATION |
| Owner/operator number | 9067818 |
| Product codes | FGE |
| Device names | FGE - Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5010 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Aomori Olympus Co., Ltd. Hirosaki Site, AOMORI OLYMPUS CO., LTD. Kuroishi Site, Gyrus ACMI, Inc., OLYMPUS MEDICAL SYSTEMS CORP. |
| Establishment registrations | 8010047, 9614641, 3011050570, 3014769442 |
| FEI numbers | 3002807795, 3003995201, 3011050570, 3014769442 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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