Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171548 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)
This device is a Stent, Drain, and Dilator for the Biliary Ducts, designed for controlled dilation of biliary strictures or obstructions. It features graduated, tapered tips to progressively widen the ductal lumen, reducing trauma while facilitating passage of contrast or therapeutic instruments. The cotton-tipped variants provide gentle dilation, while the fusion and Soehendra models incorporate reinforced designs for enhanced stability during use. All variants adhere to the classification of Class II medical devices under FDA regulations.
The catheters are supplied as single-use, non-sterile devices intended for sterile preparation prior to use in endoscopic or percutaneous biliary procedures. They are compatible with MRI environments and come in various sizes to accommodate different ductal diameters. Authorized under FDA 510K and MDD, these devices are regulated under 21 CFR 876.5010 and fall under the FGE product code. Sterilization instructions must be followed per manufacturer guidelines to ensure safety and efficacy.
Manufacturer's product page: Advance Micro® 14 Ultra Low-Profile PTA Balloon Catheter
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171548 | Class II | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
Sources (2)
- FDA 510(k) K171548 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026