FDA 510(k) Application Details - K230925

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K230925
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Alton (Shanghai) Medical Instruments Co. Ltd No.24 Building Jinshao Rd. 1688.Baoshan District. Shanghai 200949 CN Other 510(k) Applications for this Company
Contact	Vivian Li Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2023
Decision Date	09/27/2023
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