Magnetically Maneuvered Capsule Endoscopy System
The Magnetically Maneuvered Capsule Endoscopy System is a Class 2 gastroenterology device consisting of an ingestible capsule and magnetic controller used for visualization of the stomach and duodenum; the capsule contains a wireless camera while an external magnetic controller is magnetically coupled with the capsule to control its location and viewing direction. It requires 510(k) clearance and is regulated under 21 CFR 876.1310 within the Gastroenterology and Urology medical specialty. The product code is QKZ. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QKZ
- Device Class
- FDA class 2
- Regulation Number
- 876.1310
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | Jul 31, 2024 | Substantially Equivalent | Anx Robotica Corp |
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Oct 03, 2023 | Substantially Equivalent | Anx Robotica Corporation |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Apr 13, 2023 | Substantially Equivalent | Anx Robotica Corp |
| 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 | Nov 22, 2022 | Substantially Equivalent | Anx Robotica Corp |
| K203192 | NaviCam Xpress Stomach System | May 04, 2021 | Substantially Equivalent | Anx Robotica Corp |
| DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | May 22, 2020 | Unknown | Anx Robotica, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.