Marathon Stent With Fusion Technology
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060624 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Marathon Stent With Fusion Technology is a biliary stent, drain, and dilator designed for the biliary ducts. It is intended to maintain patency in obstructed bile ducts during endoscopic procedures, featuring a soft sock at the proximal end to reduce duodenal content reflux while preserving antegrade bile flow.
This preloaded stent system is available in a 10 French diameter with lengths of 5, 7, 9, or 12 centimeters. It is intended for single-use and is not MRI-compatible. The device holds FDA 510(k) clearance (K060624) and is regulated under product code FGE and regulation number 876.5010.
Marathon Stent With Fusion Technology
Frequently asked questions
What is the Marathon Stent With Fusion Technology used for?
This device is designed to maintain patency in obstructed bile ducts during endoscopic procedures. Its soft proximal sock reduces duodenal content reflux while preserving antegrade bile flow, ensuring effective drainage and minimizing complications.
How is the Marathon Stent With Fusion Technology supplied?
The stent comes preloaded in a system, available in a single diameter of 10 French. Lengths vary (5, 7, 9, or 12 centimeters), allowing clinicians to select the appropriate size for the patient’s anatomy and clinical needs.
Is the Marathon Stent With Fusion Technology sterile and single-use?
Yes, the device is intended for single-use only. It is preloaded in a sterile package, ensuring readiness for immediate use in endoscopic procedures without the need for additional sterilization.
Can this stent be reused or is it MRI-compatible?
The Marathon Stent With Fusion Technology is explicitly designed for single-use and is not intended for reuse. Additionally, it is not MRI-compatible, so it should not be used in MRI environments.
What regulatory pathway does this device follow?
The device holds FDA 510(k) clearance under the product code FGE and regulation number 876.5010. It was reviewed by the Gastroenterology and Urology Advisory Committee and classified as substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MARATHON STENT WITH FUSION TECHNOLOGY (K060624) — FDA 510(k) | Innolitics, Marathon Stent With Fusion Technology 510 (k) FDA Premarket ..., PDF K060624 - Marathon Stent With Fusion Technology, PDF Kckoi2.q r~o~,A ,z - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060624 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA 510(k) K060624 24 fields · synced Oct 1, 2026