VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)— 510(k) K251175

Name: FDA 510(k) clearance K251175
Creator: U.S. Food and Drug Administration
Published: 2025-07-17

Substantially Equivalent

Alafair Biosciences

FDA 510(k) clearance K251175 for VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201), Substantially Equivalent on 2025-07-17. 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: 2025-04-16
Decision date: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXI

view all

K260245 — SILKBridge2026-04-09
K253363 — NeuroSpan Bridge2026-01-17
K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)2025-07-22
K242113 — Nerve Wrap (07-DW-001-TAB)2025-04-02
K243889 — Remplir (4 models)2025-04-02

More clearances from Alafair Biosciences

view all

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.