Nerve Capping Device
510(k) K152684
Nerve Capping Device is a Class II device made by Polyganics Innovations BV, cleared under FDA 510(k) K152684 on 13 Jan 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152684 | Date13 Jan 2016 | StatusActive |
Official records
- FDA 510(k) database K152684
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JXI
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5275
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152684
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| NEUROCAP 1.5 mm | NC01-015/03 / 1.5 mm | 08717703990232 | — | On the market |
| NEUROCAP 2.0 mm | NC01-020/03 / 2.0 mm | 08717703990249 | — | On the market |
| NEUROCAP 2.5 mm | NC01-025/03 / 2.5 mm | 08717703990256 | — | On the market |
| NEUROCAP 3.0 mm | NC01-030/03 / 3.0 mm | 08717703990263 | — | On the market |
| NEUROCAP 4.0 mm | NC01-040/03 / 4.0 mm | 08717703990270 | — | On the market |
| NEUROCAP 5.0 mm | NC01-050/03 / 5.0 mm | 08717703990287 | — | On the market |
| NEUROCAP 6.0 mm | NC01-060/03 / 6.0 mm | 08717703990294 | — | On the market |
| NEUROCAP 7.0 mm | NC01-070/03 / 7.0 mm | 08717703990300 | — | On the market |
| NEUROCAP 8.0 mm | NC01-080/03 / 8.0 mm | 08717703990317 | — | On the market |
Similar devices
Other devices filed under FDA product code JXI (Cuff, Nerve).
- NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 by Polyganics B.V.,
- VersaWrap Nerve Protector by ALAFAIR BIOSCIENCES, INC.
- NeuroFlex CNCF2025 by COLLAGEN MATRIX, INC.
- NeuroMend CNW6025 by COLLAGEN MATRIX, INC.
- NeuraGen® PNG430 PNG-430 by Integra Lifesciences Corp.
- NERBRIDGE by Toyobo Co., Ltd.
- NeuraGen® PNG620 PNG-620 by Integra Lifesciences Corp.
- VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) by ALAFAIR BIOSCIENCES, INC.
- NEUROLAC(R) NERVE GUIDE by Polyganics B.V.,
- SURGISIS NERVE CUFF by Cook Biotech, Inc.