FDA 510(k) Application Details - K250212

Device Classification Name	More FDA Info for this Device
510(K) Number	K250212
Device Name	LapBox Power Tissue Containment System
Applicant	ARK Surgical 13 Wadi El Haj 13 Wadi El Haj 1603611 IL Other 510(k) Applications for this Company
Contact	Stav Tori Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2025
Decision Date	04/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review