NaviCam Xpress Stomach System— 510(k) K203192

Name: FDA 510(k) clearance K203192
Creator: U.S. Food and Drug Administration
Published: 2021-05-04

Substantially Equivalent

Anx Robotica Corp

FDA 510(k) clearance K203192 for NaviCam Xpress Stomach System, Substantially Equivalent on 2021-05-04. 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: 2020-10-28
Decision date: 2021-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, 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.