FDA 510(k) Application Details - K231861

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K231861
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	Covidien LLC 3062 Bunker Hill Lane Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Viviana Gonzalez Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2023
Decision Date	07/21/2023
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