GESCO UMBILI-CATH— 510(k) K911607

Name: FDA 510(k) clearance K911607
Creator: U.S. Food and Drug Administration
Published: 1991-06-11

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K911607 for GESCO UMBILI-CATH, Substantially Equivalent on 1991-06-11. Applicant: Gesco Intl., Inc.. Device class: 2.

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code FOS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1991-04-10
Decision date: 1991-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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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.