FDA 510(k) Application Details - K252012

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K252012
Device Name	Hysteroscope (And Accessories)
Applicant	Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 US Other 510(k) Applications for this Company
Contact	Irina Glazkova 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	06/27/2025
Decision Date	07/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review