DISPOSABLE URODYNAMIC CATHETER SET— 510(k) K896784

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K896784 for DISPOSABLE URODYNAMIC CATHETER SET, Substantially Equivalent on 1990-02-16. Applicant: Life-Tech Intl., Inc..

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1989-12-04
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.