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FDA 510(k)

NEUROGEN NERVE GUIDE

K-Number: K011168 · 2001-06-22

ApplicantIntegra Lifesciences Corp.
Decision Date2001-06-22
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROGEN NERVE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011168. 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 NEUROGEN NERVE GUIDE?

NEUROGEN NERVE GUIDE is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K011168.

When did NEUROGEN NERVE GUIDE receive FDA 510(k) clearance?

NEUROGEN NERVE GUIDE received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011168.

Who is the listed applicant for NEUROGEN NERVE GUIDE?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROGEN NERVE GUIDE?

The FDA product code for NEUROGEN NERVE GUIDE is JXI.

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Related Devices (Code: JXI)

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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

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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