Tendon Protect (50242)— 510(k) K243843

Substantially Equivalent

Kerecis Limited

FDA 510(k) clearance K243843 for Tendon Protect (50242), Substantially Equivalent on 2025-06-04. Applicant: Kerecis Limited. Device class: 2.

Clearance details

Applicant: Kerecis Limited
Product code: Code OWY
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2024-12-13
Decision date: 2025-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Isafjordur, IS

Download summary PDF View on FDA.gov ↗

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