FDA 510(k) Application Details - K250493

Device Classification Name	Gastrointestinal Motility System, Capsule   More FDA Info for this Device
510(K) Number	K250493
Device Name	Gastrointestinal Motility System, Capsule
Applicant	AnX Robotica Corporation 6010 W Spring Creek Parkway Plano, TX 75024 US Other 510(k) Applications for this Company
Contact	Tim Thomas Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NYV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2025
Decision Date	05/21/2025
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