URI-CATH SYSTEM— 510(k) K852490

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K852490 for URI-CATH SYSTEM, Substantially Equivalent on 1985-11-05. Applicant: Gesco Intl., Inc..

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1985-06-12
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.