Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Olympus Small Intestinal Capsule Endoscope System

K-Number: K173459 · 2018-03-13

ApplicantOlympus Medical Systems Corp.
Decision Date2018-03-13
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 2018-03-13 under approval number K173459. 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 2018-03-13. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K173459.

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

Olympus Small Intestinal Capsule Endoscope System received FDA 510(k) clearance on 2018-03-13, under approval number K173459.

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.

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 Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

View all 77 devices →

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.

↑