FDA Product Code HRX: Arthroscope
FDA product code HRX covers arthroscopes used for direct visualization of joint interiors during arthroscopic surgery.
These rigid optical instruments are inserted through small portals into the joint to visualize cartilage, ligaments, and synovial tissue during diagnostic and therapeutic arthroscopic procedures. They are used in knee, shoulder, hip, ankle, and wrist arthroscopy.
HRX devices are Class II medical devices, regulated under 21 CFR 888.1100 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medos International SARL, Arthrex, Inc. and W.O.M. World of Medicine GmbH.
List of Arthroscope devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Arthroscope devices (product code HRX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →