COOK NEPHROSTOMY DILATION BALLOON CATHETER SET— 510(k) K024050

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K024050 for COOK NEPHROSTOMY DILATION BALLOON CATHETER SET, Substantially Equivalent on 2003-02-27. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 2002-12-09
Decision date: 2003-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.