Data / Medical devices / Australia / Renerve Ltd
Renerve Ltd: FDA-registered device maker in Melbourne Victoria, Australia, 1 510(k) clearance
Renerve Ltd is registered with the FDA (registration 3022317591) in Melbourne Victoria, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 10, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022317591
- Address
- L 10 99 Queen Street, Melbourne Victoria, Australia, 3000
- Owner or operator
- ReNerve Ltd (10084457)
- Roles
- Specification developer
- First device listed
- April 1, 2022
- Registered through
- 2027
- Brand names listed
- NervAlign Nerve Cuff
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Nerve | JXI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2022 | K202234 | NervAlign Nerve Cuff | JXI | Substantially Equivalent | Renerve, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 10, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.