NaviCam Capsule Endoscope System with NaviCam Stomach Capsule— 510(k) DEN190037

Name: FDA 510(k) clearance DEN190037
Creator: U.S. Food and Drug Administration
Published: 2020-05-22

Unknown

Anx Robotica, Inc.

FDA 510(k) clearance DEN190037 for NaviCam Capsule Endoscope System with NaviCam Stomach Capsule, Unknown on 2020-05-22. Applicant: Anx Robotica, Inc.. Device class: 2.

Clearance details

Applicant: Anx Robotica, Inc.
Product code: Code QKZ
Device class: Class 2
Regulation: 21 CFR 876.1310
Advisory panel: Gastroenterology, Urology
Date received: 2019-08-13
Decision date: 2020-05-22
Decision: Unknown
Clearance type: Direct
Location: Dover, DE, US

View on FDA.gov ↗

Recent devices under product code QKZ

view all

K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)2024-07-31
K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether2023-10-03
K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System2023-04-13
K221608 — 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 Tether2022-11-22
K203192 — NaviCam Xpress Stomach System2021-05-04

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