FDA 510(k) Application Details - K201355

Device Classification Name	Insufflator, Hysteroscopic   More FDA Info for this Device
510(K) Number	K201355
Device Name	Insufflator, Hysteroscopic
Applicant	Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 34 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Alexey Davidov Other 510(k) Applications for this Contact
Regulation Number	884.1700   More FDA Info for this Regulation Number
Classification Product Code	HIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2020
Decision Date	07/22/2020
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