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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
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