CIRCLE NEPHROSTOMY CATHETER SET— 510(k) K961933

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K961933 for CIRCLE NEPHROSTOMY CATHETER SET, Substantially Equivalent on 1996-07-18. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1996-05-17
Decision date: 1996-07-18
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.