Oculeve, Inc.: FDA clearances and approvals
Oculeve, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQJ | Intranasal Electrostimulation Device | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160030 | De Novo | Intranasal Electrostimulation Device | 2017-04-24 |
Recalls
openFDA lists no recalls under a recalling firm named Oculeve, 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.
Device clinical trials
Oculeve, Inc. is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03097614: Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment (Completed, started 2017-03-31)
- NCT02970799: Tear Production by Nasal Neurostimulation Compared to Active Control (Completed, started 2016-08-31)
- NCT02798289: Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator (Completed, started 2016-06)
- NCT02680158: A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome (Completed, started 2016-01-31)
- NCT02526290: Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator (Completed, started 2015-08-31)
Frequently asked questions
How many FDA 510(k) clearances does Oculeve, Inc. have?
Oculeve, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Oculeve, Inc. make?
Its most frequent FDA product codes are PQJ (Intranasal Electrostimulation Device, 1).
Has Oculeve, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Oculeve, Inc. Related entities may recall under other names.
Next steps
- See all 0 Oculeve, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQJ, Oculeve, 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.