DEN220052 is an FDA 510(k) submission for the BrachyGel Vaginal Hydrogel Packing System. This device is classified as a Vaginal Hydrogel Packing System (Class II - Special Controls, product code QXR).
Submitted by Brachyfoam, Inc. D/B/A Advaray (Charlottesville, US). The FDA issued a Not Cleared (DENG) decision on August 22, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5735. 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..
| 510(k) Number | DEN220052 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 25, 2022 |
| Decision Date | August 22, 2023 |
| Days to Decision | 362 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | QXR - Vaginal Hydrogel Packing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5735 |
| 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. |