FDA 510(k) Application Details - K190512

Device Classification Name	Snare, Flexible   More FDA Info for this Device
510(K) Number	K190512
Device Name	Snare, Flexible
Applicant	Intelligent Endoscopy 4740 Commercial Park Ct, Suite 1 Clemmons, NC 27012 US Other 510(k) Applications for this Company
Contact	Melissa Clark Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2019
Decision Date	11/22/2019
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