FDA 510(k) Application Details - K212323

Device Classification Name	More FDA Info for this Device
510(K) Number	K212323
Device Name	Instinct Plus Endoscopic Clipping Device
Applicant	Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Scottie Fariole Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2021
Decision Date	08/25/2021
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