BrachyGel Vaginal Hydrogel Packing System
FDA 510(k) clearance DEN220052 · decided 2023-08-22
Clearance details
- K-number
- DEN220052
- Device name
- BrachyGel Vaginal Hydrogel Packing System
- Applicant
- Brachyfoam, Inc. D/B/A Advaray
- Decision
- Unknown
- Date received
- 2022-08-25
- Decision date
- 2023-08-22
- Days to decision
- 362 days
- Clearance type
- Direct
- Product code
- QXR
- Device class
- 2
- Regulation number
- 892.5735
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.