NaviCam Xpress Stomach System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230694 FDA 510(k)
- FDA Product Code
- QKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1310 FDA 510(k)
- Regulation Number
- 876.1310 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NaviCam Xpress Stomach System is a Magnetically Maneuvered Capsule Endoscopy System, designed for non-invasive gastrointestinal imaging. It employs a wireless capsule equipped with imaging capabilities, guided through the stomach via external magnetic fields for precise navigation and comprehensive visualization of the mucosal surface.
This system is intended for use in Gastroenterology and Urology settings and is supplied as a single-use, non-sterile device. It operates under FDA 510(k) clearance (K230694, Special Review, Class II) and includes three distinct registration numbers (3016544248, 3015198783, 3017400296) under regulation 876.1310. The device requires no special storage conditions beyond standard room temperature and is intended for professional medical use only.
Frequently asked questions
What types of medical specialties can use the NaviCam Xpress Stomach System, and how is it primarily utilized in those settings?
The NaviCam Xpress Stomach System is designed for use in Gastroenterology and Urology settings. It is a magnetically maneuvered capsule endoscopy system that provides non-invasive imaging of the gastrointestinal mucosal surface, allowing precise navigation through the stomach for detailed visualization. This makes it particularly useful for diagnosing and evaluating conditions within the upper GI tract, such as ulcers, tumors, or inflammatory diseases, while also supporting urological assessments where GI imaging may be relevant.
Is the NaviCam Xpress Stomach System intended for single-use or reusable applications, and what does this mean for its handling and disposal?
The NaviCam Xpress Stomach System is supplied as a single-use device, meaning each capsule is intended for one-time use only. This design reduces the risk of cross-contamination and eliminates the need for sterilization or reprocessing between patients. Clinicians should follow standard single-use medical device protocols, including proper disposal after use in accordance with local healthcare facility guidelines.
What storage conditions are required for the NaviCam Xpress Stomach System, and how should it be handled before use?
The system does not require any special storage conditions beyond standard room temperature. It is intended for professional medical use, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, ensure the device is inspected for damage and that the packaging remains intact to maintain its non-sterile but single-use integrity.
How is the NaviCam Xpress Stomach System regulated, and what does its FDA clearance status indicate about its safety and effectiveness?
The NaviCam Xpress Stomach System holds FDA 510(k) clearance (K230694) under Special Review, classified as a Class II device under regulation 876.1310. This clearance indicates that the FDA has determined it is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. While clearance does not guarantee clinical outcomes, it signifies that the device meets regulatory standards for marketing in the U.S. under the specified indications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NaviCam® Xpress™ Stomach System* - AnX Robotics, Products - AnX Robotics, NaviCam Xpress Stomach System - Medical XPRT, NaviCam Xpress Stomach System, NaviCam Xpress System (K230694) — FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230694 | Class II | Active |
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Manufacturer
- Manufacturer
- Anx Robotica Corp
Sources (1)
- FDA 510(k) K230694 24 fields · synced Sep 19, 2026