FDA device listing
Disposable Balloons,ManoScan 3D HRM A300 module,ManoScan base pressure module ( A120),Manoscan catheters,ManoScan…
FDA device listing 1993921557 · GIVEN IMAGING INC.
Key facts
| Proprietary names | Disposable Balloons,ManoScan 3D HRM A300 module,ManoScan base pressure module ( A120),Manoscan catheters,ManoScan Impedance module (Z) A200,ManoScan sw,ManoScan System,ManoShield (disposable sanitary sheaths),ManoView AR sw,ManoView ESO sw |
|---|---|
| Owner/operator | GIVEN IMAGING INC. |
| Owner/operator number | 10091555 |
| Premarket submissions | K151086 |
| Product codes | FFX |
| Device names | FFX - System, Gastrointestinal Motility (Electrical) |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1725 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | GIVEN IMAGING LTD., Given Imaging Vietnam Co., Ltd. |
| Establishment registrations | 9710107, 3007662958 |
| FEI numbers | 3003348376, 3007662958 |
| Establishment operations | 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