VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)— 510(k) K251655

Name: FDA 510(k) clearance K251655
Creator: U.S. Food and Drug Administration
Published: 2025-07-18

Substantially Equivalent

Alafair Biosciences

FDA 510(k) clearance K251655 for VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1), Substantially Equivalent on 2025-07-18. Applicant: Alafair Biosciences. Device class: 2.

Clearance details

Applicant: Alafair Biosciences
Product code: Code OWW
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-05-30
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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