MIROCAM CAPSULE ENDOSCOPE SYSTEM— 510(k) K140751

Substantially Equivalent

Intromedic Co., Ltd.

FDA 510(k) clearance K140751 for MIROCAM CAPSULE ENDOSCOPE SYSTEM, Substantially Equivalent on 2014-06-30. Applicant: Intromedic Co., Ltd..

Clearance details

Applicant: Intromedic Co., Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-25
Decision date: 2014-06-30
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.