E-Z EM PERCUPUMP 2001 CT INJECTOR— 510(k) K011160

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K011160 for E-Z EM PERCUPUMP 2001 CT INJECTOR, Substantially Equivalent on 2001-05-16. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2001-04-16
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Westbury, NY, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.