FDA 510(k) Application Details - K231260

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K231260
Device Name	Hysteroscope (And Accessories)
Applicant	Suzhou AcuVu Medical Technology Co., Ltd. B1-212, Bio-Nano Park, 218 Xinghu Street, Suzhou Industrial Park Suzhou 215125 CN Other 510(k) Applications for this Company
Contact	Sam Mostafavi 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	05/01/2023
Decision Date	03/05/2024
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