Ultravision2 System Integrated Monopolar L-Hook (H/S)— 510(k) K231298

Name: FDA 510(k) clearance K231298
Creator: U.S. Food and Drug Administration
Published: 2023-10-31

Substantially Equivalent

Alesi Surgical, Ltd.

FDA 510(k) clearance K231298 for Ultravision2 System Integrated Monopolar L-Hook (H/S), Substantially Equivalent on 2023-10-31. Applicant: Alesi Surgical, Ltd.. Device class: 2.

Clearance details

Applicant: Alesi Surgical, Ltd.
Product code: Code PQM
Device class: Class 2
Regulation: 21 CFR 878.5050
Advisory panel: General, Plastic Surgery
Date received: 2023-05-04
Decision date: 2023-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cardiff, GB

Download summary PDF View on FDA.gov ↗

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