FDA 510(k) Application Details - K242668

Device Classification Name	Anoscope And Accessories   More FDA Info for this Device
510(K) Number	K242668
Device Name	Anoscope And Accessories
Applicant	Gastro Concepts, LLC 24A Trolley Square #1400 Wilmington, DE 19806 US Other 510(k) Applications for this Company
Contact	Rick Brown Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2024
Decision Date	12/13/2024
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