URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING— 510(k) K981344

Substantially Equivalent

Uresil Corp.

FDA 510(k) clearance K981344 for URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING, Substantially Equivalent on 1998-09-10. Applicant: Uresil Corp..

Clearance details

Applicant: Uresil Corp.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1998-04-09
Decision date: 1998-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

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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.