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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 a medical device manufactured by Ankon Technologies Co., Ltd.. It received FDA 510(k) clearance on 2022-12-02 under approval 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. It is manufactured by Ankon Technologies Co., Ltd.. The 510(k) number is K221590.

When was NaviCam Small Bowel Capsule Endoscopy System approved by the FDA?

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

What company makes NaviCam Small Bowel Capsule Endoscopy System?

NaviCam Small Bowel Capsule Endoscopy System is manufactured by Ankon Technologies Co., Ltd..

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

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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 Ankon Technologies Co., Ltd.

DEN230027NaviCam ProScan

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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