FDA 510(k) Application Details - K190621

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K190621
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	Sumitomo Bakelite Co., Ltd 5-8, Higashi-Shinagawa 2-chome Shinagawa-ku 1400002 JP Other 510(k) Applications for this Company
Contact	Shiro Agehama Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2019
Decision Date	04/23/2019
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