NEUROGEN NERVE GUIDE
FDA 510(k) clearance K011168 · decided 2001-06-22
Clearance details
- K-number
- K011168
- Device name
- NEUROGEN NERVE GUIDE
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-17
- Decision date
- 2001-06-22
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- JXI
- Device class
- 2
- Regulation number
- 882.5275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve disc recall (Z-1287-2013) | Integra LifeSciences Corporation | 2013-05-10 |