K-number	K192339
Device name	TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
Applicant	Wilson-Cook Medical, Inc.
Product code	KNS
Device class	Class II
Decision date	Jan 30, 2020
Decision	Substantially Equivalent
Regulation	876.4300

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View the full FDA submission: accessdata.fda.gov

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TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

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