FDA 510(k) Application Details - K223020

Device Classification Name	More FDA Info for this Device
510(K) Number	K223020
Device Name	VS3-Iridium System (VS3-IR)
Applicant	Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz 4934829 IL Other 510(k) Applications for this Company
Contact	Guy Wroclawski Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	10/28/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review