NerveTape
Biocircuit Technologies, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3024511918 | 3024511918 | BIOCIRCUIT TECHNOLOGIES | 1 | N | 2026-01-01 | 1819 Peachtree Rd Ne Ste 350 Atlanta GA US 30309 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| G517CW2040 | ConformaWrap - ConformaWrap is a surgical implant designed to protect a damaged peripheral nerve, serving as a non-constricting interface between the nerve and the surroundingtissue. ConformaWrap is composed of an extracellular matrix (ECM), which is fully remodeled during the healing process. When hydrated, ConformaWrap is easy tohandle, soft, pliable, nonfriable, and porous. ConformaWrap is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. | 1-800-905-2204 | support@biocircuit.com |
| G517CW4080 | ConformaWrap - ConformaWrap is a surgical implant designed to protect a damaged peripheral nerve, serving as a non-constricting interface between the nerve and the surroundingtissue. ConformaWrap is composed of an extracellular matrix (ECM), which is fully remodeled during the healing process. When hydrated, ConformaWrap is easy tohandle, soft, pliable, nonfriable, and porous. ConformaWrap is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. | 1-800-905-2204 | support@biocircuit.com |
| G517NT15140 | Nerve Tape® - Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surroundingtissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coaptednerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold theends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. | 1-800-905-2204 | support@biocircuit.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 309501 | 1851501979 | K242113 | Nerve Wrap (07-DW-001-TAB) | JXI | 2025-04-02 |
| 309501 | 1779125830 | K233533 | NerveTape | JXI | 2024-02-12 |
| 309501 | 1716054715 | K210665 | Nerve Tape | JXI | 2022-07-15 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JXI | 3 | 2025-04-02 |
Biocircuit Technologies, Inc.
BioCircuit Technologies, Incorporated
2025-09-10
2025-09-10
2024-02-29
2024-02-29
2024-02-29
2024-02-29
2024-02-29
2024-02-29
2024-02-29