FDA 510(k) Application Details - K250820

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K250820
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Sinolinks Medical Innovation, Inc. No.10 Ziwei Road, Zhonglou Zone Chang Zhou 213023 CN Other 510(k) Applications for this Company
Contact	Juan Zhao Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2025
Decision Date	07/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review