K251505

Substantially Equivalent

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

Applicant: Alafair Biosciences
Product code: JXI
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 ↗

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