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FDA 510(k)

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 Tether

K-Number: K221608 · 2022-11-22

ApplicantAnx Robotica Corp
Decision Date2022-11-22
Product CodeQKZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 Tether is a medical device manufactured by Anx Robotica Corp. It received FDA 510(k) clearance on 2022-11-22 under approval number K221608. 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 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?

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 Tether is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Anx Robotica Corp. The 510(k) number is K221608.

When was 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 Tether approved by the FDA?

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 Tether received FDA 510(k) clearance on 2022-11-22, under approval number K221608.

What company makes 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 Tether?

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 Tether is manufactured by Anx Robotica Corp.

What is the FDA product code for 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 Tether?

The FDA product code for 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 Tether is QKZ.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT00702533 A New Method for Determining Gastric Acid Output Using a Wireless Capsule COMPLETED NCT04605302 Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms COMPLETED NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT07317076 GT Metabolic Magnet System in Adults With Gastrointestinal Disorders RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION

Other Devices by Anx Robotica Corp

K191087IntraMarX Radiopaque Markers K201106IntraMarX 3D Radiopaque Marker K203192NaviCam Xpress Stomach System 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. K203192NaviCam Xpress Stomach SystemAnx 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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