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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 the device name listed in this FDA 510(k) record. The listed applicant is Biocircuit Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) 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. The listed applicant is Biocircuit Technologies, Inc.. The 510(k) number is K242113.

When did Nerve Wrap (07-DW-001-TAB) receive FDA 510(k) clearance?

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

Who is the listed applicant for Nerve Wrap (07-DW-001-TAB)?

The FDA 510(k) record lists Biocircuit Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Biocircuit Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233533NerveTapeK210665Nerve Tape

Related Devices (Code: JXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair BiosciencesK251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair BiosciencesK243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.

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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