VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)— 510(k) K251505

Name: FDA 510(k) clearance K251505
Creator: U.S. Food and Drug Administration
Published: 2025-07-22

Substantially Equivalent

Alafair Biosciences

FDA 510(k) clearance K251505 for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1), Substantially Equivalent on 2025-07-22. Applicant: Alafair Biosciences. Device class: 2.

Clearance details

Applicant: Alafair Biosciences
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2025-05-16
Decision date: 2025-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXI

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K260245 — SILKBridge2026-04-09
K253363 — NeuroSpan Bridge2026-01-17
K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)2025-07-17
K242113 — Nerve Wrap (07-DW-001-TAB)2025-04-02
K243889 — Remplir (4 models)2025-04-02

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K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)2025-07-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.