FDA 510(k) Application Details - K240074

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K240074
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Shenzhen Besdata Technology Co., Ltd. 503, Building #2, Xinnantian Industrial Park, No. 3179 Laokeng Community, Longtian Street, Pingshan District Shenzhen 518128 CN Other 510(k) Applications for this Company
Contact	Xiaohong Lu 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	01/10/2024
Decision Date	10/04/2024
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