FDA 510(k) Application Details - K232003

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K232003
Device Name	Hysteroscope (And Accessories)
Applicant	Guangzhou Red Pine Medical Instrument Co.,Ltd. 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou 510200 CN Other 510(k) Applications for this Company
Contact	Xiangfei Li Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2023
Decision Date	02/12/2024
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