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FDA 510(k)

Nerve Wrap (07-DW-001-TAB)

K-Number: K242113 · 2025-04-02

ApplicantBiocircuit Technologies, Inc.
Decision Date2025-04-02
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nerve Wrap (07-DW-001-TAB) is a medical device manufactured by Biocircuit Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-02 under approval number K242113. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nerve Wrap (07-DW-001-TAB)?

Nerve Wrap (07-DW-001-TAB) is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by Biocircuit Technologies, Inc.. The 510(k) number is K242113.

When was Nerve Wrap (07-DW-001-TAB) approved by the FDA?

Nerve Wrap (07-DW-001-TAB) received FDA 510(k) clearance on 2025-04-02, under approval number K242113.

What company makes Nerve Wrap (07-DW-001-TAB)?

Nerve Wrap (07-DW-001-TAB) is manufactured by Biocircuit Technologies, Inc..

What is the FDA product code for Nerve Wrap (07-DW-001-TAB)?

The FDA product code for Nerve Wrap (07-DW-001-TAB) is JXI.

Other Devices by Biocircuit Technologies, Inc.

K233533NerveTape

Related Devices (Code: JXI)

K162741AxoGuard Nerve ConnectorCook Biotech Incorporated K152967NERBRIDGEToyobo Co., Ltd. K152684Nerve Capping DevicePolyganics Innovations BV K163446AxoGen Nerve CapAxogen Corporation K170656Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc. K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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