MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.— 510(k) K052168

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K052168 for MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC., Substantially Equivalent on 2006-02-16. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-09
Decision date: 2006-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.