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FDA 510(k)

NEUROTUBE

K-Number: K983007 · 1999-03-22

ApplicantNeuroregen, LLC
Decision Date1999-03-22
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Neuroregen, LLC. It received FDA 510(k) clearance on 1999-03-22 under 510(k) number K983007. 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 NEUROTUBE?

NEUROTUBE is a medical device that received FDA 510(k) clearance on 1999-03-22. The listed applicant is Neuroregen, LLC. The 510(k) number is K983007.

When did NEUROTUBE receive FDA 510(k) clearance?

NEUROTUBE received FDA 510(k) clearance on 1999-03-22, under 510(k) number K983007.

Who is the listed applicant for NEUROTUBE?

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

What is the FDA product code for NEUROTUBE?

The FDA product code for NEUROTUBE is JXI.

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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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