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510(k) Data Aggregation
K Number
K172288Device Name
Fusion OMNI Sphincterotome
Manufacturer
Wilson-Cook Medical, Inc./ Cook Endoscopy
Date Cleared
2018-04-17
(260 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Wilson-Cook Medical, Inc./ Cook Endoscopy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Device Description
The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.
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