FDA 510(k) Application Details - K192876

Device Classification Name	Endoscopic Central Control Unit   More FDA Info for this Device
510(K) Number	K192876
Device Name	Endoscopic Central Control Unit
Applicant	Smith & Nephew 150 Minuteman Rd Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Janice Haselton Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2019
Decision Date	02/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review