Optus Arthroscope & Mini-Arthroscope Accessories

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953913 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Optus Sinuscopes and Accessories

  Class II

  FDA 510(k) K944656 Active Cleared 26 Jan 1995

• Optus Hysteroscopes and Contact Hysteroscopes

  Class II

  FDA 510(k) K945265 Active Cleared 12 Sep 1995

• Optus Arthroscopes and Mini-Arthroscopes

  Class II

  FDA 510(k) K945267 Active Cleared 23 May 1995

• Optus Laryngoscopes

  Class I

  FDA 510(k) K945269 Active Cleared 7 Nov 1994

• Optus Bronchoscopes

  Class II

  FDA 510(k) K945268 Active Cleared 21 Dec 1995

• Optus Cystoscopes and Pediatric Cystoscopes

  Class II

  FDA 510(k) K945262 Active Cleared 26 May 1995

See all devices from Optus, Inc. →

• Are these arthroscope accessories reusable or single-use, and how should they be handled to maintain sterility?

  The Optus Arthroscope & Mini-Arthroscope Accessories are designed as reusable medical instruments. To ensure sterility and patient safety, they must be processed according to strict sterile processing protocols, including cleaning, disinfection, and sterilization between uses. Proper handling and maintenance are critical to preserve device integrity and functionality for repeated surgical applications.

• What types of joint procedures can these accessories support, and how do they enable minimally invasive surgery?

  These accessories are used for visual examination, diagnosis, and surgical intervention within joints, enabling procedures like meniscectomy (removal of damaged cartilage), synovectomy (removal of inflamed tissue), and ligament repair. By providing direct visualization through arthroscopy, they allow surgeons to perform these interventions with smaller incisions, reducing trauma and accelerating recovery compared to traditional open surgery.

• How are these devices classified by the FDA, and what does that mean for their use in orthopedic settings?

  The Optus Arthroscope & Mini-Arthroscope Accessories fall under FDA product code HRX and have received 510(k) clearance, meaning they are deemed substantially equivalent to legally marketed devices already on the market. This classification confirms they meet regulatory standards for arthroscopic instruments and can be legally used in orthopedic surgical settings for the intended purposes outlined in the description.

• What storage and handling precautions should be taken to ensure these reusable instruments remain effective?

  Since these are reusable instruments, they must be stored in a clean, dry environment and protected from physical damage or contamination. After use, they should undergo comprehensive sterile processing, including cleaning, disinfection, and sterilization (e.g., autoclaving or ethylene oxide) before reuse. Proper storage also requires adherence to manufacturer guidelines to prevent degradation of materials or functionality over time.