K-number	K230089
Device name	ETHICON LINX® Esophagus Sizing Tool
Applicant	Torax Medical, Inc.
Product code	QJN
Device class	Class II
Decision date	Feb 9, 2023
Decision	Substantially Equivalent
Regulation	876.5360

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Source

View the full FDA submission: accessdata.fda.gov

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ETHICON LINX® Esophagus Sizing Tool

Everything you need for a 510(k) submission. Nothing you don't.