Brachyfoam, Inc. D/B/A Advaray: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Brachyfoam, Inc. D/B/A Advaray”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QXR | Vaginal Hydrogel Packing System | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220052 | De Novo | Vaginal Hydrogel Packing System | 2023-08-22 |
Recalls
openFDA lists no recalls under a recalling firm named Brachyfoam, Inc. D/B/A Advaray.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Brachyfoam, Inc. D/B/A Advaray?
FDA lists 0 510(k) clearances under the applicant name “Brachyfoam, Inc. D/B/A Advaray”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Brachyfoam, Inc. D/B/A Advaray?
The most frequent FDA product codes under this applicant name are QXR (Vaginal Hydrogel Packing System, 1).
Next steps
- See all 0 Brachyfoam, Inc. D/B/A Advaray clearances with predicates and recalls
- Run predicate analysis for product code QXR, Brachyfoam, Inc. D/B/A Advaray's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.