INJEKT CYSTO FLEXIBLE INJECTION NEEDLE— 510(k) K113634

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K113634 for INJEKT CYSTO FLEXIBLE INJECTION NEEDLE, Substantially Equivalent on 2012-02-14. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2011-12-09
Decision date: 2012-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Limerick, IE

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Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.