NervAlign Nerve Cuff— 510(k) K202234
Substantially EquivalentRenerve, Ltd.
FDA 510(k) clearance K202234 for NervAlign Nerve Cuff, Substantially Equivalent on 2022-02-10. Applicant: Renerve, Ltd.. Device class: 2.
Clearance details
- Applicant
- Renerve, Ltd.
- Product code
- Code JXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Melbourne, AU
Recent devices under product code JXI
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