Fidmi Low Profile Enteral Feeding Device— 510(k) K191844

Name: FDA 510(k) clearance K191844
Creator: U.S. Food and Drug Administration
Published: 2019-09-30

Substantially Equivalent

Fidmi Medical, Ltd.

FDA 510(k) clearance K191844 for Fidmi Low Profile Enteral Feeding Device, Substantially Equivalent on 2019-09-30. Applicant: Fidmi Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Fidmi Medical, Ltd.
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-09
Decision date: 2019-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea Business Park, Caesarea, IL

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.