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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 the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-22 under 510(k) 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. The listed applicant is Alafair Biosciences. The 510(k) number is K251505.

When did VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) receive FDA 510(k) clearance?

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

Who is the listed applicant for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

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

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.

Other records listing Alafair Biosciences as applicant

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.

K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)K240817VersaWrapK232029VersaWrap Nerve ProtectorK213163VersaWrapK203600VersaWrap

View all 10 devices →

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.K251175VersaWrap 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.K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.

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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