FDA 510(k) Application Details - K242634

Device Classification Name	More FDA Info for this Device
510(K) Number	K242634
Device Name	PuraStat
Applicant	3-D Matrix Europe SAS 11 Chemin des Petites Brosses Caluire et Cuire 69300 FR Other 510(k) Applications for this Company
Contact	Audrey Vion Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2024
Decision Date	01/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review