Fusion OMNI Sphincterotome
by Wilson-Cook Medical Inc./Cook Endoscopy
510(k) K172288
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172288 | Date17 Apr 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Fusion OMNI Sphincterotome is an electrosurgical, endoscopic device designed for sphincterotomy procedures. It is used to incise or cut sphincters, particularly in the biliary or pancreatic ductal systems, facilitating access for diagnostic or therapeutic interventions. The device integrates electrosurgical capabilities with a precision-tipped design to ensure controlled tissue dissection during endoscopic procedures.
This single-use, non-sterile device is intended for use in gastroenterology and urology settings. It is supplied as a sterile, disposable instrument and must be handled according to standard endoscopic protocols. The Fusion OMNI Sphincterotome is Class II under FDA regulations and holds a 510(k) clearance (K172288) for substantial equivalence. Multiple reference codes (e.g., FS-OMNI-ACRO-35-260, G34693) identify specific variants, including those with DomeTip technology for enhanced ductal access.
Other devices from Wilson-Cook Medical Inc./Cook Endoscopy
Questions
AI-generated answers, 1 Oct 2026
What is the Fusion OMNI Sphincterotome used for?
The Fusion OMNI Sphincterotome is an electrosurgical endoscopic device designed specifically for sphincterotomy procedures. It incises or cuts sphincters—particularly in the biliary or pancreatic ductal systems—to create controlled access for diagnostic or therapeutic interventions, such as stone removal or stent placement. Its precision-tipped design ensures safe and accurate tissue dissection during endoscopic procedures.
Is the Fusion OMNI Sphincterotome single-use or reusable?
The Fusion OMNI Sphincterotome is a single-use device. It is supplied sterile and intended for one-time use only, adhering to standard endoscopic protocols to maintain patient safety and procedural sterility. Reuse is not recommended or approved.
How is the Fusion OMNI Sphincterotome supplied, and what does sterile mean in this context?
The device is supplied as a sterile, disposable instrument, packaged for immediate clinical use. Sterility in this context means it has undergone validated terminal sterilization (likely gamma irradiation or ethylene oxide) to eliminate microorganisms, ensuring it is safe for direct patient contact without additional reprocessing. Always follow manufacturer guidelines for handling sterile packaging.
What distinguishes the DomeTip variants of the Fusion OMNI Sphincterotome?
The DomeTip variants (e.g., reference codes like FS-OMNI-ACRO-35-260) feature an enhanced tip design optimized for improved ductal access. This modification allows for better navigation and precision during sphincterotomy in complex anatomical structures, reducing the risk of complications such as ductal perforation or incomplete incision.
How should the Fusion OMNI Sphincterotome be stored before use?
Store the device in its original, unopened sterile packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and moisture. Avoid exposure to chemicals or contaminants. Once opened, use immediately to preserve sterility; do not store or reuse. Follow the manufacturer’s instructions for specific storage conditions, including temperature ranges if applicable.