14Fr Colon Decompression Set, Macon Colon Decompression Set— 510(k) K171619

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K171619 for 14Fr Colon Decompression Set, Macon Colon Decompression Set, Substantially Equivalent on 2017-08-01. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code FEG
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-02
Decision date: 2017-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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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.