FDA 510(k) Application Details - K242128

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K242128
Device Name	Instrument, Biopsy
Applicant	Xaga Surgical Alnarpsgatan 81 Helsingborg SE-256 67 SE Other 510(k) Applications for this Company
Contact	Anders Grim Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2024
Decision Date	02/27/2025
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