QXR — Vaginal Hydrogel Packing System Class II
FDA product code QXR covers "Vaginal Hydrogel Packing System", a Class II medical device regulated under 21 CFR 892.5735. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXR
- Device Class
- Class II
- Regulation Number
- 892.5735
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220052 | brachyfoam, inc. d/b/a advaray | BrachyGel Vaginal Hydrogel Packing System | August 22, 2023 |