UMBILI-CATH-S-DL— 510(k) K940952

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K940952 for UMBILI-CATH-S-DL, Substantially Equivalent on 1994-07-29. Applicant: Gesco Intl., Inc..

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 1994-03-01
Decision date: 1994-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.