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FDA 510(k)

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)

K-Number: K251505 · 2025-07-22

ApplicantAlafair Biosciences
Decision Date2025-07-22
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) is a medical device manufactured by Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-22 under approval number K251505. 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 VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) is a medical device that received FDA 510(k) clearance on 2025-07-22. It is manufactured by Alafair Biosciences. The 510(k) number is K251505.

When was VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) approved by the FDA?

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) received FDA 510(k) clearance on 2025-07-22, under approval number K251505.

What company makes VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) is manufactured by Alafair Biosciences.

What is the FDA product code for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

The FDA product code for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) 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 Alafair Biosciences

K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)

Related Devices (Code: JXI)

K162741AxoGuard Nerve ConnectorCook Biotech Incorporated 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

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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