Quadsense (Quadsense and Quadsense Pro)— 510(k) K252524

Name: FDA 510(k) clearance K252524
Creator: U.S. Food and Drug Administration
Published: 2025-09-09

Substantially Equivalent

Eventum Orthopaedics, Ltd.

FDA 510(k) clearance K252524 for Quadsense (Quadsense and Quadsense Pro), Substantially Equivalent on 2025-09-09. Applicant: Eventum Orthopaedics, Ltd.. Device class: 2.

Clearance details

Applicant: Eventum Orthopaedics, Ltd.
Product code: Code ONN
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-08-11
Decision date: 2025-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Leeds, GB

Download summary PDF View on FDA.gov ↗

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