OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE— 510(k) K970716

Substantially Equivalent

Opticon Medical, Inc.

FDA 510(k) clearance K970716 for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE, Substantially Equivalent on 1997-05-16. Applicant: Opticon Medical, Inc..

Clearance details

Applicant: Opticon Medical, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-27
Decision date: 1997-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.