Arthoscope

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

510(k) Number

K960805 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modified Auto Suture Endoscopic Gia Surg. Stapler*

  Class II

  FDA 510(k) K900129 Active Cleared 27 Feb 1990

• Auto Suture(R) Endoscopic Gia(Tm) Surgical Stapler

  Class II

  FDA 510(k) K892233 Active Cleared 28 Apr 1989

• Caprosyn Absorbable Suture

  Class II

  FDA 510(k) K032586 Active Cleared 17 Nov 2003

• Auto Suture Disposable Gia Surg. Stapler

  Class I

  FDA 510(k) K801590 Active Cleared 4 Aug 1980

• Endoscope Suture & Carrier

  Class II

  FDA 510(k) K912973 Active Cleared 27 Sep 1991

• Modified Surgiport Disposable Trocar and Sleeve

  Class I

  FDA 510(k) K903419 Active Cleared 9 Aug 1990

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• What is the Arthroscope used for in surgical procedures?

  The Arthroscope is designed for visual inspection and minimally invasive procedures within joints. It allows surgeons to examine internal structures such as cartilage, ligaments, and bone surfaces through a small incision. This enables both diagnostic evaluations and therapeutic interventions, such as debridement, synovectomy, or meniscectomy, reducing the need for larger surgical openings.

• Is the Arthroscope supplied as a reusable or single-use device?

  The Arthroscope is supplied as a reusable device. It is intended for repeated use in sterile orthopedic surgical settings, adhering to established protocols for cleaning, sterilization, and maintenance to ensure safety and performance across multiple procedures.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Arthroscope was cleared by the FDA through a Traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device. The clearance was granted under product code HRX, with a decision date of April 10, 1996, and classified under the Orthopedic advisory committee.

• How is the Arthroscope classified under FDA product codes?

  The Arthroscope falls under the FDA product code HRX, which categorizes it as an orthopedic instrument. This classification aligns with its intended use for arthroscopic procedures, ensuring it meets regulatory standards for safety and performance in joint surgeries.

• What type of surgical settings is the Arthroscope intended for?

  The Arthroscope is specifically intended for use in orthopedic surgical settings. Its design supports minimally invasive techniques, making it suitable for procedures where precision and reduced trauma to surrounding tissues are critical, such as joint repairs or diagnostic evaluations.