MiroCam Capsule Endoscope System— 510(k) K143663

Substantially Equivalent

Intromedic Co., Ltd.

FDA 510(k) clearance K143663 for MiroCam Capsule Endoscope System, Substantially Equivalent on 2015-03-17. Applicant: Intromedic Co., Ltd..

Clearance details

Applicant: Intromedic Co., Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2014-12-23
Decision date: 2015-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guro-Gu , Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEZ

product code NEZ

Death: 11
Injury: 218
Total: 229

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.