K-number	K232476
Device name	Disposable Sphincterotome
Applicant	Zhejiang Soudon Medical Technology Co., Ltd.
Product code	KNS
Device class	Class II
Decision date	Nov 7, 2023
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Sphincterotome

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