FDA 510(k) Application Details - K243568

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K243568
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Lindsey Ebke 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	11/18/2024
Decision Date	01/17/2025
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