FDA 510(k) Application Details - K230089

Device Classification Name	More FDA Info for this Device
510(K) Number	K230089
Device Name	ETHICON LINX« Esophagus Sizing Tool
Applicant	Torax Medical Inc. 4188 Lexington Avenue North Shoreview, MN 55126 US Other 510(k) Applications for this Company
Contact	Brian Godwin 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	01/12/2023
Decision Date	02/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review