E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS— 510(k) K841720

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K841720 for E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS, Substantially Equivalent on 1984-07-26. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1984-04-25
Decision date: 1984-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.