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FDA 510(k)

Nerve Capping Device

K-Number: K152684 · 2016-01-13

ApplicantPolyganics Innovations BV
Decision Date2016-01-13
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nerve Capping Device is a medical device manufactured by Polyganics Innovations BV. It received FDA 510(k) clearance on 2016-01-13 under approval number K152684. 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 Capping Device?

Nerve Capping Device is a medical device that received FDA 510(k) clearance on 2016-01-13. It is manufactured by Polyganics Innovations BV. The 510(k) number is K152684.

When was Nerve Capping Device approved by the FDA?

Nerve Capping Device received FDA 510(k) clearance on 2016-01-13, under approval number K152684.

What company makes Nerve Capping Device?

Nerve Capping Device is manufactured by Polyganics Innovations BV.

What is the FDA product code for Nerve Capping Device?

The FDA product code for Nerve Capping Device is JXI.

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Related PubMed Literature

PMID: 40003250 Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices. Children (Basel, Switzerland) (2025)

Related Devices (Code: JXI)

K162741AxoGuard Nerve ConnectorCook Biotech Incorporated K152967NERBRIDGEToyobo Co., Ltd. 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.

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