Urethral Catheter Tray (Latex)

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

510(k) Number

K901184 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

• Pre-Filled Sysringe W/Sterile Water

  Class II

  FDA 510(k) K943829 Active Cleared 21 Nov 1994

• Dual Port Enteral Y-Adaptor

  Class II

  FDA 510(k) K923168 Active Cleared 17 Jun 1994

• External Leg Bag

  Class I

  FDA 510(k) K901219 Active Cleared 27 Jun 1990

• Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride Solution

  Class II

  CE/MDR FDA 510(k) K943830 Active Cleared 21 Nov 1994

• Bulb Irrigation Tray

  Class II

  FDA 510(k) K900736 Active Cleared 17 Apr 1990

• Suction Catheter, Sterile

  Class I

  FDA 510(k) K902814 Active Cleared 17 Aug 1990

See all devices from Orion Life Systems, Inc. →

• What is the Orion Latex Urethral Catheter Tray used for?

  The Orion Latex Urethral Catheter Tray is designed for urological procedures, specifically for urethral catheterization. It facilitates the drainage or collection of urine from the urinary tract by providing a sterile, flexible tubular catheter and associated accessories for insertion through the urethra. This kit is intended for use in clinical settings like hospitals or medical offices.

• Is the Orion Latex Urethral Catheter Tray single-use or reusable?

  The Orion Latex Urethral Catheter Tray is explicitly designed for single-use only. This ensures sterility and reduces the risk of contamination or infection during catheterization procedures, adhering to clinical best practices for patient safety.

• What materials are included in the tray, and is it sterile?

  The tray contains a flexible tubular latex catheter and associated accessories for catheterization. It is supplied as a sterile urethral catheterization kit, ensuring readiness for immediate clinical use without additional sterilization steps.

• How should the Orion Latex Urethral Catheter Tray be stored?

  Since the tray is sterile and single-use, it should be stored in its original packaging in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage maintains sterility and integrity until use.

• Does this device require any special handling or regulatory compliance?

  The Orion Latex Urethral Catheter Tray has received FDA 510(k) clearance (K901184) under FDA regulation 876.5130, confirming its compliance with U.S. medical device standards. Clinicians should follow manufacturer guidelines and local protocols for proper use, disposal, and adherence to latex safety precautions if needed.