FDA device listing
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether,NaviCam Tether,NaviCam Xpress Stomach…
FDA device listing 1773563426 · AnX Robotica Corp.
Key facts
| Proprietary names | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether,NaviCam Tether,NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam |
|---|---|
| Owner/operator | AnX Robotica Corp. |
| Owner/operator number | 10062363 |
| Premarket submissions | K221608 |
| Product codes | QKZ |
| Device names | QKZ - Magnetically Maneuvered Capsule Endoscopy System |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1310 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | ANX ROBOTICA CORP. |
| Establishment registrations | 3016544248 |
| FEI numbers | 3016544248 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, 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