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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 the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corporation. It received FDA 510(k) clearance on 2024-01-05 under 510(k) 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. The listed applicant is Anx Robotica Corporation. The 510(k) number is K233229.

When did NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether receive FDA 510(k) clearance?

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

Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

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

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

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.

NCT07633847A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.NOT_YET_RECRUITINGNCT04605302Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal SymptomsCOMPLETEDNCT07649720NaviCam Patency Capsule to Verify Gastrointestinal PatencyNOT_YET_RECRUITINGNCT05704010Videocapsule Endoscopy in Lynch SyndromeRECRUITINGNCT05949268Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small BowelRECRUITINGNCT05004012Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric MotilityCOMPLETED

Other records listing Anx Robotica Corporation 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.

K250493MotiliCap GI Monitoring SystemK241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam TetherK230694NaviCam Xpress Stomach System, NaviCam Xpress SystemK221608NaviCam 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 TetherK203192NaviCam Xpress Stomach System

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Related Devices (Code: NEZ)

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.

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.

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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