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FDA 510(k)

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

K-Number: K241934 · 2024-07-31

ApplicantAnx Robotica Corp
Decision Date2024-07-31
Product CodeQKZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) is a medical device manufactured by Anx Robotica Corp. It received FDA 510(k) clearance on 2024-07-31 under approval number K241934. 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 Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)?

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) is a medical device that received FDA 510(k) clearance on 2024-07-31. It is manufactured by Anx Robotica Corp. The 510(k) number is K241934.

When was NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) approved by the FDA?

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) received FDA 510(k) clearance on 2024-07-31, under approval number K241934.

What company makes NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)?

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) is manufactured by Anx Robotica Corp.

What is the FDA product code for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)?

The FDA product code for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/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 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

Related Devices (Code: QKZ)

DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. K203192NaviCam Xpress Stomach SystemAnx Robotica Corp 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

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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