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FDA 510(k)

Olympus Small Intestinal Capsule Endoscope System

K-Number: K183053 · 2019-03-05

ApplicantOlympus Medical Systems Corp.
Decision Date2019-03-05
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Olympus Small Intestinal Capsule Endoscope System is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-03-05 under approval number K183053. 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 Olympus Small Intestinal Capsule Endoscope System?

Olympus Small Intestinal Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2019-03-05. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K183053.

When was Olympus Small Intestinal Capsule Endoscope System approved by the FDA?

Olympus Small Intestinal Capsule Endoscope System received FDA 510(k) clearance on 2019-03-05, under approval number K183053.

What company makes Olympus Small Intestinal Capsule Endoscope System?

Olympus Small Intestinal Capsule Endoscope System is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Olympus Small Intestinal Capsule Endoscope System?

The FDA product code for Olympus Small Intestinal Capsule Endoscope System is NEZ.

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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)

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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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