NEUROCAP 3.0 mm
by Polyganics Innovations B.V.
NEUROCAP 3.0 mm (NC01-030/03) is a Class II device made by Polyganics Innovations B.V., cleared under FDA 510(k) K152684 on 13 Jan 2016 and listed in FDA GUDID since 2 Feb 2016 (UDI-DI 08717703990263), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08717703990263 | Date2 Feb 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152684 | Date13 Jan 2016 | StatusActive |
Official records
- AccessGUDID record 08717703990263
- FDA 510(k) database K152684
Across registries
- FDA 510(k) K152684 decided 13 Jan 2016 Active
- FDA GUDID UDI-DI 08717703990263 listed 2 Feb 2016 Listed
Timeline
- Cleared FDA 510(k) K152684
- Listed FDA GUDID 08717703990263
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neurocap
- Generic name
- Nerve guide, synthetic polymer, bioabsorbable
- Model / Ref / Catalog
- 3.0 mm, NC01-030/03
- Primary DI / UDI-DI
- 08717703990263
- 510(k) Number
- FDA product code
- JXI
- GMDN term
- Nerve guide, synthetic polymer, bioabsorbable
- Device class
- Class II
- Regulation number
- 882.5275
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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