FDA 510(k) Application Details - K222155

Device Classification Name	More FDA Info for this Device
510(K) Number	K222155
Device Name	Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
Applicant	Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin 214415 CN Other 510(k) Applications for this Company
Contact	Jianwei Pan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2022
Decision Date	09/16/2022
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