NaviCam Xpress Stomach System, NaviCam Xpress System— 510(k) K230694

Name: FDA 510(k) clearance K230694
Creator: U.S. Food and Drug Administration
Published: 2023-04-13

Substantially Equivalent

Anx Robotica Corp

FDA 510(k) clearance K230694 for NaviCam Xpress Stomach System, NaviCam Xpress System, Substantially Equivalent on 2023-04-13. Applicant: Anx Robotica Corp. Device class: 2.

Clearance details

Applicant: Anx Robotica Corp
Product code: Code QKZ
Device class: Class 2
Regulation: 21 CFR 876.1310
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-13
Decision date: 2023-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.