FDA 510(k) Application Details - K201035

Device Classification Name	More FDA Info for this Device
510(K) Number	K201035
Device Name	ETHICON Linx Esophagus Sizing Tool
Applicant	Torax Medical, Inc. 4188 Lexington Avenue, N Shoreview, MN 55126 US Other 510(k) Applications for this Company
Contact	Joseph Ciccone Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2020
Decision Date	07/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review