FDA 510(k) Application Details - K232401

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K232401
Device Name	Insufflator, Laparoscopic
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	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2023
Decision Date	12/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review