FDA 510(k) Application Details - DEN220052

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220052
Device Name	BrachyGel Vaginal Hydrogel Packing System
Applicant	BrachyFoam, Inc. d/b/a Advaray 722 Preston Ave. Suite 108 Charlottesville, VA 22903 US Other 510(k) Applications for this Company
Contact	Timothy Showalter, MD, MPH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2022
Decision Date	08/22/2023
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review