MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM— 510(k) K040248

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K040248 for MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM, Substantially Equivalent on 2004-02-17. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-03
Decision date: 2004-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam, IL

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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.