Assurance Medical: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Assurance Medical”, 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 |
|---|---|---|---|
| NKA | System, Documentation, Breast Lesion | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN020001 | De Novo | System, Documentation, Breast Lesion | 2003-01-31 |
Recalls
openFDA lists no recalls under a recalling firm named Assurance Medical.
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 Assurance Medical?
FDA lists 0 510(k) clearances under the applicant name “Assurance Medical”, 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 Assurance Medical?
The most frequent FDA product codes under this applicant name are NKA (System, Documentation, Breast Lesion, 1).
Next steps
- See all 0 Assurance Medical clearances with predicates and recalls
- Run predicate analysis for product code NKA, Assurance Medical'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.