GIVEN DIAGNOSTIC SYSTEM— 510(k) K053639

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K053639 for GIVEN DIAGNOSTIC SYSTEM, Substantially Equivalent on 2006-05-08. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2005-12-30
Decision date: 2006-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneaam, IL

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.