NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether— 510(k) K231960

Name: FDA 510(k) clearance K231960
Creator: U.S. Food and Drug Administration
Published: 2023-10-03

Substantially Equivalent

Anx Robotica Corporation

FDA 510(k) clearance K231960 for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether, Substantially Equivalent on 2023-10-03. Applicant: Anx Robotica Corporation. Device class: 2.

Clearance details

Applicant: Anx Robotica Corporation
Product code: Code QKZ
Device class: Class 2
Regulation: 21 CFR 876.1310
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-03
Decision date: 2023-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
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.