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FDA 510(k)

NaviCam Xpress Stomach System

K-Number: K203192 · 2021-05-04

Decision Date2021-05-04
Product CodeQKZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NaviCam Xpress Stomach System is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2021-05-04 under 510(k) 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. The listed applicant is Anx Robotica Corp. The 510(k) number is K203192.

When did NaviCam Xpress Stomach System receive FDA 510(k) clearance?

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

Who is the listed applicant for NaviCam Xpress Stomach System?

The FDA 510(k) record lists Anx Robotica Corp as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Anx Robotica Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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