FDA 510(k) Application Details - K243382

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K243382
Device Name	Hysteroscope (And Accessories)
Applicant	RZ Medizintechnik GmbH Unter Ha▀len 20/22 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Daniela Lang 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	10/31/2024
Decision Date	06/03/2025
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