FDA 510(k) Application Details - K190099

Device Classification Name	Resectoscope   More FDA Info for this Device
510(K) Number	K190099
Device Name	Resectoscope
Applicant	Corinth MedTech, Inc. 1601 S. De Anza Blvd, Suite 200 Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Sandeep Saboo Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FJL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2019
Decision Date	03/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review