FDA 510(k) Application Details - K233263

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K233263
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Hangzhou Kangji Medical Instrument Co., Ltd. No. 1668 Chunjiang East Road, Economic Development Zone Tonglu Hangzhou 311501 CN Other 510(k) Applications for this Company
Contact	Martin Sun 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	09/29/2023
Decision Date	04/09/2024
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