INJEKT CYSTO FLEXIBLE INJECTION NEEDLE— 510(k) K113634
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K113634 for INJEKT CYSTO FLEXIBLE INJECTION NEEDLE, Substantially Equivalent on 2012-02-14. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- 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, through . 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.