Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon A…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171989 FDA 510(k)
- FDA Product Code
- ODD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula, designed for use in diagnostic and therapeutic procedures within the biliary and pancreatic ducts. It facilitates cannulation of the bile duct and pancreatic duct during ERCP, enabling visualization and intervention via fluoroscopy or endoscopy. Variants include standard, angled, double-lumen, and radiopaque configurations to accommodate different anatomical challenges and clinical needs.
The catheters are supplied as single-use, non-sterile devices intended for use in controlled medical settings such as endoscopy suites. They are available in multiple configurations, including sizes like 0.035-inch (e.g., Classic ERCP Catheter, 3.5–5.5 Fr) and double-lumen variants with radiopaque bands for enhanced visibility. Regulatory compliance includes FDA 510(k) clearance under Traditional review and MDD conformity, with classification under Device Class II (876.1500). Storage and handling must adhere to standard sterile processing protocols prior to use.
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. Sources consulted: Huibregtse-Katon® ERCP Catheter - Cook Medical, Scope medical, Classic ERCP Catheter - Cook Medical, ERCP cannulation and sphincterotomy devices, Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse ...
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 | K171989 | Class II | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
Sources (2)
- FDA 510(k) K171989 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026