FDA 510(k) Application Details - K231323

Device Classification Name	Enteroscope And Accessories   More FDA Info for this Device
510(K) Number	K231323
Device Name	Enteroscope And Accessories
Applicant	Aspero Medical, Inc. 320 E. Vine Drive, Suite 101 Fort Collins, CO 80524 US Other 510(k) Applications for this Company
Contact	Mark Rentschler Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2023
Decision Date	08/31/2023
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