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FDA 510(k)

Nerve Tape

K-Number: K210665 · 2022-07-15

ApplicantBiocircuit Technologies, Incorporated
Decision Date2022-07-15
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nerve Tape is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuit Technologies, Incorporated. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K210665. 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 Tape?

Nerve Tape is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Biocircuit Technologies, Incorporated. The 510(k) number is K210665.

When did Nerve Tape receive FDA 510(k) clearance?

Nerve Tape received FDA 510(k) clearance on 2022-07-15, under 510(k) number K210665.

Who is the listed applicant for Nerve Tape?

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

What is the FDA product code for Nerve Tape?

The FDA product code for Nerve Tape is JXI.

Other records listing Biocircuit Technologies, Incorporated 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.

K242113Nerve Wrap (07-DW-001-TAB)K233533NerveTape

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.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.

Official Source

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

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