FDA 510(k) Application Details - K232911

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K232911
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Karl Storz Endovision, Inc 91 Carpenter Hill Road Charlton, MA 01507 US Other 510(k) Applications for this Company
Contact	Thomas Ostrowski Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2023
Decision Date	06/10/2024
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