Scion Neurostim, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Scion Neurostim, LLC”, 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 |
|---|---|---|---|
| QAR | Thermal Vestibular Stimulator For Headache | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170023 | De Novo | Thermal Vestibular Stimulator For Headache | 2018-03-26 |
Recalls
openFDA lists no recalls under a recalling firm named Scion Neurostim, LLC.
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 Scion Neurostim, LLC is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05580211: Neuromodulation for Schizophrenia (Recruiting, started 2023-10-03)
- NCT04797611: STEM-Parkinson's Disease (Completed, started 2022-05-19)
- NCT02270866: Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia (Completed, started 2014-10)
- NCT01899040: A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache (Completed, started 2013-08)
- NCT01630044: Neurostimulation Device for Treatment of Migraine Headache (Completed, started 2012-05)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Scion Medical Technologies, LLC (6 510(k)s)
- Scion Cardio-Vascular, Inc. (4 510(k)s)
- Scion International, Inc. (4 510(k)s)
- Scion Cardiovascular, Inc. (1 510(k)s)
- Scion Valley, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scion Neurostim, LLC?
FDA lists 0 510(k) clearances under the applicant name “Scion Neurostim, LLC”, 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 Scion Neurostim, LLC?
The most frequent FDA product codes under this applicant name are QAR (Thermal Vestibular Stimulator For Headache, 1).
Next steps
- See all 0 Scion Neurostim, LLC clearances with predicates and recalls
- Run predicate analysis for product code QAR, Scion Neurostim, LLC'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.