Eneura Therapeutics, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Eneura Therapeutics, LLC” (first 2014, latest 2014), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 127 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 127 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OKP | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache | 2 | 1 |
Review panels
- Neurology (2)
Most recent Eneura Therapeutics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140094 | SPRINGTMS TOTAL MIGRAINE SYSTEM | OKP | 2014-05-21 | 127 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130022 | De Novo | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache | 2013-12-13 |
Recalls
openFDA lists no recalls under a recalling firm named Eneura Therapeutics, 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.
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.
- Eneura, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eneura Therapeutics, LLC?
FDA lists 1 510(k) clearance under the applicant name “Eneura Therapeutics, LLC” (first 2014, latest 2014), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eneura Therapeutics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eneura Therapeutics, LLC is 127 days.
Which FDA product codes appear under Eneura Therapeutics, LLC?
The most frequent FDA product codes under this applicant name are OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache, 2).
Next steps
- See all 1 Eneura Therapeutics, LLC clearances with predicates and recalls
- Run predicate analysis for product code OKP, Eneura Therapeutics, 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.