Neuros Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Neuros Medical, Inc.”, plus 1 PMA 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 |
|---|---|---|---|
| SAZ | Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230020 | PMA | Altius® Direct Electrical Nerve Stimulation System | 2024-08-26 |
Recalls
openFDA lists no recalls under a recalling firm named Neuros Medical, Inc..
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.
Device clinical trials
An industry sponsor named Neuros Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT02221934: Electrical Nerve Block for Amputation Pain (Active not recruiting, started 2014-10-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neuros Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Neuros Medical, Inc.”, plus 1 PMA 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 Neuros Medical, Inc.?
The most frequent FDA product codes under this applicant name are SAZ (Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb, 1).
Next steps
- See all 0 Neuros Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SAZ, Neuros Medical, Inc.'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.