FDA 510(k) Application Details - K242666

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K242666
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	GI Bionics, LLC 11107 Roselle Street Suite 213 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Ricardo Villanueva Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	KLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2024
Decision Date	02/12/2025
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