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SureTome SW Sphincterotome with DomeTip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251104

by Wilson-Cook Medical

Identifiers

510(k) Number
K251104 FDA 510(k)
FDA Product Code
KNS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SureTome SW Sphincterotome with DomeTip is an endoscopic electrosurgical device classified as a Unit, Electrosurgical, Endoscopic (With or Without Accessories). It is designed for biliary ductal cannulation and sphincterotomy procedures, facilitating access to the biliary and pancreatic ducts during endoscopic retrograde cholangiopancreatography (ERCP). The device features a DomeTip configuration, which aids in navigating and bridging difficult strictures within the ductal system.

This device is supplied as a single-use, reusable electrosurgical accessory, compatible with endoscopes featuring a minimum channel size of 4.2 mm. It is intended for use in controlled clinical settings such as gastroenterology and urology procedures. The SureTome SW Sphincterotome with DomeTip has received FDA 510(k) clearance under the Traditional pathway, with a decision date of September 29, 2025. Preloaded configurations may include an Acrobat 2 Calibrated Tip Wire Guide for enhanced cannulation support.

Frequently asked questions

What is the SureTome SW Sphincterotome with DomeTip used for?

The SureTome SW Sphincterotome with DomeTip is designed specifically for biliary ductal cannulation and sphincterotomy procedures. During endoscopic retrograde cholangiopancreatography (ERCP), it helps clinicians access and navigate the biliary and pancreatic ducts, particularly in cases involving difficult strictures. The DomeTip configuration enhances maneuverability within the ductal system, improving precision and control during these critical interventions.

Is the SureTome SW Sphincterotome with DomeTip single-use or reusable?

This device is supplied as a reusable electrosurgical accessory. It is intended for repeated use in controlled clinical settings, such as gastroenterology and urology procedures, provided it is properly cleaned, sterilized, and maintained between uses. Reusability ensures cost-effectiveness while maintaining performance for multiple procedures.

What endoscope channel size is required for compatibility with the SureTome SW Sphincterotome?

The SureTome SW Sphincterotome with DomeTip is compatible with endoscopes that have a minimum channel size of 4.2 mm. This ensures the device can be safely and effectively inserted through the endoscope’s working channel during ERCP procedures, allowing for optimal access and maneuverability within the biliary and pancreatic ducts.

Does the SureTome SW Sphincterotome come preloaded with any accessories?

Yes, the SureTome SW Sphincterotome with DomeTip may be preloaded with an Acrobat 2 Calibrated Tip Wire Guide. This wire guide provides enhanced support for cannulation, improving the precision and efficiency of accessing the biliary and pancreatic ducts during ERCP. The inclusion of this accessory helps streamline the procedure and reduce the risk of complications.

How should the SureTome SW Sphincterotome with DomeTip be stored?

Since this device is reusable, it must be stored in a clean, dry environment to prevent contamination and ensure sterility before use. Follow manufacturer guidelines for proper cleaning, disinfection, and sterilization protocols between procedures. Store the device in its original packaging or a designated sterile storage container to maintain its integrity and functionality for repeated use.

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: SureTome™ SW Sphincterotome with DomeTip® | Cook Medical, SureTome™ SW Sphincterotome with DomeTip® | Cook Medical, SureTome™ SW Sphincterotome with DomeTip® now available in the US and ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical

Sources (1)

  • FDA 510(k) K251104 24 fields · synced Oct 1, 2026