Data / Medical devices / United States / Anx Robotica Corp.
Anx Robotica Corp.: FDA-registered device maker in Plano, TX, United States, 12 510(k) clearances
Anx Robotica Corp. is registered with the FDA (registration 3016544248) in Plano, TX, United States. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 21, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016544248
- Address
- 6010 W. Spring Creek Pkwy, Plano, TX, United States, 75024
- Owner or operator
- AnX Robotica Corp. (10062363)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 16, 2020
- Registered through
- 2027
- Brand names listed
- IntraMarX 3D Radiopaque Marker, IntraMarX Radiopaque Markers, MotiliCap GI Monitoring System, NaviCam Capsule Endoscope System with NaviCam Stomach Capsule, NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Capsule/Tether, NaviCam Small Bowel Capsule Endoscopy System, NaviCam Stomach System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastrointestinal Capsule Endoscopy Analysis Software Device | QZF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gastrointestinal Motility System, Capsule | NYV | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Magnetically Maneuvered Capsule Endoscopy System | QKZ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Imaging, Gastrointestinal, Wireless, Capsule | NEZ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tether Accessory For Use In The Gastrointestinal Tract | QUN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2025 | K250493 | MotiliCap GI Monitoring System | NYV | Substantially Equivalent | Anx Robotica Corporation | accessdata.fda.gov |
| July 31, 2024 | K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | QKZ | Substantially Equivalent | Anx Robotica Corp | accessdata.fda.gov |
| January 5, 2024 | K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | NEZ | Substantially Equivalent | Anx Robotica Corporation | accessdata.fda.gov |
| December 12, 2023 | DEN230027 | NaviCam ProScan | QZF | Unknown | Ankon Technologies Co., Ltd. | accessdata.fda.gov |
| October 3, 2023 | K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | QKZ | Substantially Equivalent | Anx Robotica Corporation | accessdata.fda.gov |
| April 13, 2023 | K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | QKZ | Substantially Equivalent | Anx Robotica Corp | accessdata.fda.gov |
| December 2, 2022 | K221590 | NaviCam Small Bowel Capsule Endoscopy System | NEZ | Substantially Equivalent | Ankon Technologies Co., Ltd. | accessdata.fda.gov |
| November 22, 2022 | K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether | QKZ | Substantially Equivalent | Anx Robotica Corp | accessdata.fda.gov |
| May 4, 2021 | K203192 | NaviCam Xpress Stomach System | QKZ | Substantially Equivalent | Anx Robotica Corp | accessdata.fda.gov |
| May 22, 2020 | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | QKZ | Unknown | Anx Robotica, Inc. | accessdata.fda.gov |
| May 21, 2020 | K201106 | IntraMarX 3D Radiopaque Marker | FFX | Substantially Equivalent | Anx Robotica Corp | accessdata.fda.gov |
| December 18, 2019 | K191087 | IntraMarX Radiopaque Markers | FFX | Substantially Equivalent | Anx Robotica Corp | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Gastrointestinal, Wireless, Capsule
- All makers of Magnetically Maneuvered Capsule Endoscopy System
- All makers of System, Gastrointestinal Motility (Electrical)
- All makers of Gastrointestinal Motility System, Capsule
Updated May 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.