FDA 510(k) Application Details - K190093

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K190093
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	NxThera (A Boston Scientific Company) 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Justin Kapitan 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	01/18/2019
Decision Date	03/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review