ENTROKIT WITH MAGLINTE CATHETER— 510(k) K860441

Name: FDA 510(k) clearance K860441
Creator: U.S. Food and Drug Administration
Published: 1986-03-12

Unknown

Lafayette Pharmacal, Inc.

FDA 510(k) clearance K860441 for ENTROKIT WITH MAGLINTE CATHETER, Unknown on 1986-03-12. Applicant: Lafayette Pharmacal, Inc.. Device class: 2.

Clearance details

Applicant: Lafayette Pharmacal, Inc.
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1986-02-04
Decision date: 1986-03-12
Decision: Unknown
Clearance type: Traditional
Location: Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.