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FDA 510(k)

NaviCam Small Bowel Capsule Endoscopy System

K-Number: K221590 · 2022-12-02

ApplicantAnkon Technologies Co., Ltd.
Decision Date2022-12-02
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NaviCam Small Bowel Capsule Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Ankon Technologies Co., Ltd.. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221590. 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?

NaviCam Small Bowel Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Ankon Technologies Co., Ltd.. The 510(k) number is K221590.

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

NaviCam Small Bowel Capsule Endoscopy System received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221590.

Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System?

The FDA 510(k) record lists Ankon Technologies Co., Ltd. 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?

The FDA product code for NaviCam Small Bowel Capsule Endoscopy System 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_RECRUITINGNCT05704010Videocapsule Endoscopy in Lynch SyndromeRECRUITINGNCT05949268Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small BowelRECRUITINGNCT05004012Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric MotilityCOMPLETEDNCT06951490PillSense Use in Anemia and HemoccultENROLLING_BY_INVITATIONNCT07027826The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United StatesRECRUITING

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)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

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.

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