FDA 510(k) Application Details - K234131

Device Classification Name	More FDA Info for this Device
510(K) Number	K234131
Device Name	Resolv Endoscopic Hemostat System
Applicant	Hemostasis LLC 5000 Township Parkway St. Paul, MN 55110 US Other 510(k) Applications for this Company
Contact	Lakshmi Ganesh Bollina Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2023
Decision Date	07/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review