NerveTape
by Biocircuit Technologies, Inc.
510(k) K233533
NerveTape is a Class II device made by Biocircuit Technologies, Inc., cleared under FDA 510(k) K233533 on 12 Feb 2024, 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 | NumberK233533 | Date12 Feb 2024 | StatusActive |
Official records
- FDA 510(k) database K233533
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- Withdrawn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 K233533
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 | |||
|---|---|---|---|---|
| Nerve Tape® NT15-14 | NT15-14 / NT15-14 | G517NT15140 | Lumen/Inner Diameter 1.5 mm | On the market |
| Nerve Tape® NT20-14 | NT20-14 / NT20-14 | G517NT20140 | Lumen/Inner Diameter 2.0 mm | On the market |
| Nerve Tape® NT30-14 | NT30-14 / NT30-14 | G517NT30140 | Lumen/Inner Diameter 3.0 mm | On the market |
| Nerve Tape® NT40-16 | NT40-16 / NT40-16 | G517NT40160 | Lumen/Inner Diameter 4.0 mm | On the market |
| Nerve Tape® NT50-16 | NT50-16 / NT50-16 | G517NT50160 | Lumen/Inner Diameter 5.0 mm | On the market |
| Nerve Tape® NT60-22 | NT60-22 / NT60-22 | G517NT60220 | Lumen/Inner Diameter 6.0 mm | On the market |
| Nerve Tape® NT70-22 | NT70-22 / NT70-22 | G517NT70220 | Lumen/Inner Diameter 7.0 mm | On the market |
Similar devices
Other devices filed under FDA product code JXI (Cuff, Nerve).
- NeuroMend CNW12025 by COLLAGEN MATRIX, INC.
- NERVE CUFF by COOK BIOTECH INCORPORATED
- VersaWrap Nerve Protector by ALAFAIR BIOSCIENCES, INC.
- Nerve Tape by Biocircuit Technologies, Incorporated
- Rebuilder Nerve Guidance Conduit by Celestray Biotech Company, LLC.,
- SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 by Salumedica, LLC
- NeuroMatrix CNC3025 by COLLAGEN MATRIX, INC.
- VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) by ALAFAIR BIOSCIENCES, INC.
- NervAlign Nerve Cuff by Renerve, Ltd.
- COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE by Biom'Up Sas