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510(k) DEN220052

BrachyGel Vaginal Hydrogel Packing System by Brachyfoam, Inc. D/B/A Advaray — Product Code QXR

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: August 22, 2023
Date Received: August 25, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Vaginal Hydrogel Packing System
Device Class: Class II
Regulation Number: 892.5735
Review Panel: RA
Submission Type

A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.