FDA 510(k) Application Details - K242461

Device Classification Name	More FDA Info for this Device
510(K) Number	K242461
Device Name	IRISeg
Applicant	Intuitive Surgical Inc. 1266 Kifer Road Sunnyvale, CA 94086 US Other 510(k) Applications for this Company
Contact	Jyh-Shyan (Jesse) Lin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2024
Decision Date	12/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review