Neurosigma, Inc.: FDA clearances and approvals
Neurosigma, Inc. has 1 FDA 510(k) clearance (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 109 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 109 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Neurosigma, Inc.'s cleared 510(k)s took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 225 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QGL | Transcutaneous Nerve Stimulator For Adhd | 2 | 1 |
Review panels
- Neurology (2)
Most recent Neurosigma, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | QGL | 2024-01-16 | 109 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180041 | De Novo | Transcutaneous Nerve Stimulator For Adhd | 2019-04-19 |
Recalls
openFDA lists no recalls under a recalling firm named Neurosigma, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Neurosigma, Inc. have?
Neurosigma, Inc. has 1 FDA 510(k) clearance (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Neurosigma, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Neurosigma, Inc.'s cleared 510(k)s is 109 days.
What devices does Neurosigma, Inc. make?
Its most frequent FDA product codes are QGL (Transcutaneous Nerve Stimulator For Adhd, 2).
Has Neurosigma, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Neurosigma, Inc. Related entities may recall under other names.
Next steps
- See all 1 Neurosigma, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QGL, Neurosigma, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.