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FDA 510(k)

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

K-Number: K233229 · 2024-01-05

ApplicantAnx Robotica Corporation
Decision Date2024-01-05
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is a medical device manufactured by Anx Robotica Corporation. It received FDA 510(k) clearance on 2024-01-05 under approval number K233229. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is a medical device that received FDA 510(k) clearance on 2024-01-05. It is manufactured by Anx Robotica Corporation. The 510(k) number is K233229.

When was NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether approved by the FDA?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether received FDA 510(k) clearance on 2024-01-05, under approval number K233229.

What company makes NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is manufactured by Anx Robotica Corporation.

What is the FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

The FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is NEZ.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Anx Robotica Corporation

K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether K250493MotiliCap GI Monitoring System

Related Devices (Code: NEZ)

K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. K151635CapsoCam (SV-1)CapsoVision, Inc. K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd. K170839RAPID WebGiven Imaging , Ltd. K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems 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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