Tulavi Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Tulavi Therapeutics, Inc.” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tulavi Therapeutics, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SBG | In Situ Polymerizing Peripheral Nerve Cap | 2 | 1 |
Review panels
- Neurology (2)
Most recent Tulavi Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | SBG | 2025-09-29 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230061 | De Novo | In Situ Polymerizing Peripheral Nerve Cap | 2024-07-16 |
Recalls
openFDA lists no recalls under a recalling firm named Tulavi Therapeutics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tulavi Therapeutics, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Tulavi Therapeutics, Inc.” (first 2025, latest 2025), 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 Tulavi Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tulavi Therapeutics, Inc. is 90 days.
Which FDA product codes appear under Tulavi Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are SBG (In Situ Polymerizing Peripheral Nerve Cap, 2).
Next steps
- See all 1 Tulavi Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SBG, Tulavi Therapeutics, 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.