Arthroscope & Accessories

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

510(k) Number

K921985 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Booster Trophy 5 Motorized Scooter

  Class II

  FDA 510(k) K955275 Active Cleared 4 Nov 1996

• Flexible Fiber Optic Gynecologic Endoscope

  Class II

  FDA 510(k) K922711 Active Cleared 17 May 1994

• Pl 20/20 Infant Vision Tester

  Class I

  FDA 510(k) K883337 Active Cleared 31 Oct 1988

• Flexible Fiber-Optic Nasopharyngoscope

  Class II

  FDA 510(k) K895245 Active Cleared 17 Nov 1989

• Booster Lite 4 Motorized Scooter

  Class II

  FDA 510(k) K955276 Active Cleared 4 Nov 1996

• Optiview

  Class II

  FDA 510(k) K972520 Active Cleared 29 Sep 1997

See all devices from Optimed Technologies, Inc. →

• What is the Optimed Arthroscope & Accessories used for?

  The Optimed Arthroscope & Accessories is designed for internal visualization and minimally invasive surgical procedures within joint spaces, such as the knee, shoulder, or elbow. It enables orthopedic surgeons to inspect joint conditions, remove damaged tissue, and perform repairs with enhanced precision. The system’s associated accessories—like probes, shavers, and irrigation tools—support these interventions by allowing controlled manipulation and tissue management during arthroscopic surgery.

• Is the Optimed Arthroscope & Accessories reusable or single-use?

  This device is supplied as a reusable system. Between uses, it must undergo proper sterilization to maintain hygiene and safety standards. Reusability is common for arthroscopes in clinical settings, as long as rigorous cleaning and sterilization protocols are followed to prevent contamination and ensure device integrity.

• What accessories are included with the Optimed Arthroscope & Accessories?

  The system includes essential arthroscopic accessories such as probes, shavers, and irrigation tools. These components work together to enhance functionality during surgery, enabling precise tissue management, irrigation of the joint space, and removal of debris or damaged tissue. The specific tools are designed to complement the arthroscope’s capabilities for optimal surgical outcomes.

• How should the Optimed Arthroscope & Accessories be stored?

  Storage must comply with the manufacturer’s guidelines to preserve the device’s functionality and sterility. Since it is reusable, it should be stored in a clean, dry environment, protected from physical damage or contamination. Proper packaging and handling are critical to maintaining the device’s performance and ensuring it remains ready for use in subsequent procedures.

• What regulatory pathway was followed for the Optimed Arthroscope & Accessories?

  The device received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) in 1993. This classification reflects that the device’s design and performance meet regulatory standards for electrically powered endoscopes under product code HRX, ensuring its safety and effectiveness for arthroscopic procedures in clinical settings.