Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc— 510(k) K191498

Unknown

Cook Incorporated

FDA 510(k) clearance K191498 for Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc, Unknown on 2020-01-29. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code LJE
Advisory panel: Unknown
Date received: 2019-06-05
Decision date: 2020-01-29
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, 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.