FDA 510(k) Application Details - K231298

Device Classification Name	More FDA Info for this Device
510(K) Number	K231298
Device Name	Ultravision2Ö System Integrated Monopolar L-Hook (H/S)Ö
Applicant	Alesi Surgical Ltd. Cardiff Medicentre, Heath Park Cardiff CF14 4UJ GB Other 510(k) Applications for this Company
Contact	Dominic Griffiths Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2023
Decision Date	10/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review