Major Set-Up Tray

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

510(k) Number

K912159 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Sterile Disposable Urine Collector & Accessories

  Class II

  FDA 510(k) K913223 Active Cleared 4 Sep 1991

• Central Venous Catheter Dressing Change Tray

  Class II

  FDA 510(k) K912158 Active Cleared 23 Oct 1991

• Major Basin Tray

  Class I

  FDA 510(k) K912104 Active Cleared 9 Aug 1991

• Shower Chairs

  Class I

  FDA 510(k) K922045 Active Cleared 26 May 1992

• Powermatic Treatment Table

  Class I

  FDA 510(k) K933581 Active Cleared 5 Nov 1993

• Latex Patient Examination Gloves

  Class I

  FDA 510(k) K911081 Active Cleared 21 Mar 1991

See all devices from Medical Device Inspection Co., Inc. →

• What types of medical procedures is this tray designed to support, and why is it considered reusable?

  The Major Set-Up Tray from Medical Device Inspection Co., Inc. is specifically designed to organize instruments and supplies for gastroenterology and urology procedures. It is intended for reusable use because it is supplied non-sterile and must be cleaned and sterilized by the user before each use, ensuring compliance with clinical hygiene standards.

• How is the tray supplied, and what does that mean for its handling before use?

  The tray is supplied non-sterile, meaning it is not pre-sterilized and must undergo cleaning and sterilization by the facility before reuse. This ensures proper infection control but requires adherence to the facility’s reprocessing protocols.

• Is there a specific regulatory pathway or approval status for this device?

  The Major Set-Up Tray received FDA 510(k) clearance (K912159) under the Traditional 510(k) review pathway on August 29, 1991. It was determined substantially equivalent to a legally marketed predicate device, with the review conducted by the Gastroenterology and Urology (GU) advisory committee.

• What does the advisory committee classification (GU) mean in terms of its intended use?

  The Gastroenterology, Urology (GU) advisory committee classification indicates that the device was evaluated within the context of gastroenterology and urology procedures, but it does not define its clinical indication. Instead, it reflects the regulatory filing category used by the FDA to categorize submissions, not the device’s purpose.