LOPEZ VALVE WITH NG SUMP TUBE— 510(k) K921104

Name: FDA 510(k) clearance K921104
Creator: U.S. Food and Drug Administration
Published: 1992-10-26

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K921104 for LOPEZ VALVE WITH NG SUMP TUBE, Substantially Equivalent on 1992-10-26. Applicant: Icu Medical, Inc.. Device class: 2.

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code FEG
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-09
Decision date: 1992-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FEG

product code FEG

Death: 2
Total: 2

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.