FDA 510(k) Application Details - K222705

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K222705
Device Name	Catheter, Nephrostomy
Applicant	YouCare Technology Co., Ltd. (Wuhan) Great Wall Science and Technology Park East Lake Development Zone, Wuhan Wuhan CN Other 510(k) Applications for this Company
Contact	Bing Hu Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2022
Decision Date	05/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review