GIVEN DIAGNOSTIC IMAGING SYSTEM— 510(k) DEN010002

Unknown

Given Imaging , Ltd.

FDA 510(k) clearance DEN010002 for GIVEN DIAGNOSTIC IMAGING SYSTEM, Unknown on 2001-08-01. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-11
Decision date: 2001-08-01
Decision: Unknown
Clearance type: Post-NSE
Location: Ra'Ananna 43373, IL

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.