RESONANCE METALLIC URETERAL STENT— 510(k) K063742
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K063742 for RESONANCE METALLIC URETERAL STENT, Substantially Equivalent on 2007-05-08. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code FAD
- Device class
- Class 2
- Regulation
- 21 CFR 876.4620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Limerick, IE
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- K230909 — EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- K213946 — Compass BDS Biliary Stent
Adverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
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.