FDA 510(k) Application Details - K233190

Device Classification Name	More FDA Info for this Device
510(K) Number	K233190
Device Name	ENFit Adaptor
Applicant	Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin 214415 CN Other 510(k) Applications for this Company
Contact	Camel Zhou Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	01/18/2024
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