FDA 510(k) Application Details - DEN240007

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240007
Device Name	BioHealx Anal Fistula Device
Applicant	Signum Surgical Limited Galway Harbour Enterprise Par, New Docks, The Docks Galway H91 NNY6 IE Other 510(k) Applications for this Company
Contact	Moshe Zilversmit Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2024
Decision Date	07/01/2024
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review