Device class
Class II
Regulation 876.1310
Total clearances
6
2020-05-22 → 2024-07-31
Definition
What is Magnetically Maneuvered Capsule Endoscopy System
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.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1310
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 91110 |
CPT
|
— |
High
|
Esophagus or gastric mucosa endoscopy by capsule; standard code for magnetically controlled capsule endoscopy |
| 91200 |
CPT
|
— |
Medium
|
Endoscopic ultrasound (EUS); may apply if ultrasound guidance component is documented |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-07-31 |
K241934 |
Anx Robotica Corp
|
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) |
| 2023-10-03 |
K231960 |
Anx Robotica Corporation
|
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether |
| 2023-04-13 |
K230694 |
Anx Robotica Corp
|
NaviCam Xpress Stomach System, NaviCam Xpress System |
| 2022-11-22 |
K221608 |
Anx Robotica Corp
|
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 |
| 2021-05-04 |
K203192 |
Anx Robotica Corp
|
NaviCam Xpress Stomach System |
| 2020-05-22 |
DEN190037 |
Anx Robotica, Inc.
|
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule |