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)

MiroCam Capsule Endoscope System

K-Number: K170438 · 2018-01-30

ApplicantIntromedic Co., Ltd.
Decision Date2018-01-30
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MiroCam Capsule Endoscope System is a medical device manufactured by Intromedic Co., Ltd.. It received FDA 510(k) clearance on 2018-01-30 under approval number K170438. 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 MiroCam Capsule Endoscope System?

MiroCam Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2018-01-30. It is manufactured by Intromedic Co., Ltd.. The 510(k) number is K170438.

When was MiroCam Capsule Endoscope System approved by the FDA?

MiroCam Capsule Endoscope System received FDA 510(k) clearance on 2018-01-30, under approval number K170438.

What company makes MiroCam Capsule Endoscope System?

MiroCam Capsule Endoscope System is manufactured by Intromedic Co., Ltd..

What is the FDA product code for MiroCam Capsule Endoscope System?

The FDA product code for MiroCam Capsule Endoscope System is NEZ.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT06748911 Navicam for Detection of Barrett's Esophagus RECRUITING NCT02910479 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius) COMPLETED

Other Devices by Intromedic Co., Ltd.

K180732MiroCam Capsule Endoscope System K252617MiroCam® Capsule Endoscope System

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.

↑