510(k) DEN220052
DEN220052 is an FDA 510(k) premarket notification submitted by Brachyfoam, Inc. D/B/A Advaray for the device "BrachyGel Vaginal Hydrogel Packing System". The FDA issued a decision of De Novo Granted on August 22, 2023. The device falls under product code QXR (Vaginal Hydrogel Packing System), a Class II device regulated under 21 CFR 892.5735.
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.