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FDA 510(k)

NaviCam Xpress Stomach System

K-Number: K203192 · 2021-05-04

ApplicantAnx Robotica Corp
Decision Date2021-05-04
Product CodeQKZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NaviCam Xpress Stomach System is a medical device manufactured by Anx Robotica Corp. It received FDA 510(k) clearance on 2021-05-04 under approval number K203192. The device is classified under product code QKZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviCam Xpress Stomach System?

NaviCam Xpress Stomach System is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Anx Robotica Corp. The 510(k) number is K203192.

When was NaviCam Xpress Stomach System approved by the FDA?

NaviCam Xpress Stomach System received FDA 510(k) clearance on 2021-05-04, under approval number K203192.

What company makes NaviCam Xpress Stomach System?

NaviCam Xpress Stomach System is manufactured by Anx Robotica Corp.

What is the FDA product code for NaviCam Xpress Stomach System?

The FDA product code for NaviCam Xpress Stomach System is QKZ.

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Other Devices by Anx Robotica Corp

K191087IntraMarX Radiopaque Markers K201106IntraMarX 3D Radiopaque Marker K221608NaviCam 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 Tether K230694NaviCam Xpress Stomach System, NaviCam Xpress System K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

Related Devices (Code: QKZ)

DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. K221608NaviCam 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 TetherAnx Robotica Corp K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam TetherAnx Robotica Corporation K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)Anx Robotica Corp

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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