Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AxoGuard Nerve Connector

K-Number: K162741 · 2016-10-31

ApplicantCook Biotech Incorporated
Decision Date2016-10-31
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AxoGuard Nerve Connector is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-10-31 under approval number K162741. 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 AxoGuard Nerve Connector?

AxoGuard Nerve Connector is a medical device that received FDA 510(k) clearance on 2016-10-31. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K162741.

When was AxoGuard Nerve Connector approved by the FDA?

AxoGuard Nerve Connector received FDA 510(k) clearance on 2016-10-31, under approval number K162741.

What company makes AxoGuard Nerve Connector?

AxoGuard Nerve Connector is manufactured by Cook Biotech Incorporated.

What is the FDA product code for AxoGuard Nerve Connector?

The FDA product code for AxoGuard Nerve Connector is JXI.

Related Clinical Trials

NCT07283861 Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection ACTIVE_NOT_RECRUITING

Other Devices by Cook Biotech Incorporated

K160136Flowable Wound Matrix K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K161000Biodesign Otologic Repair Graft K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K162934Biodesign Parastomal Hernia Repair Graft K170016Biodesign Fistula Plug

View all 13 devices →

Related Devices (Code: JXI)

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 K180222Reaxon PlusMedovent GmbH

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.

↑