FDA 510(k) Application Details - K200404

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K200404
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Jennifer Edouard 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	02/19/2020
Decision Date	12/03/2020
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