NHMC Urethral Catheterization Tray

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

510(k) Number

K962254 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• National Medical Healthcare Custom Ob/Gyn Kits, Trays, or Packs

  Class II

  FDA 510(k) K972013 Active Cleared 26 Aug 1997

• Nhmc Foley Catheterization Tray

  Class II

  FDA 510(k) K960566 Active Cleared 29 Feb 1996

• Nhmc Irrigation Tray

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  Unclassified

  FDA 510(k) K960523 Active Cleared 4 Apr 1996

• National Medical Healthcare Custom Orthopedic Kits and Trays

  Class I

  FDA 510(k) K971317 Active Cleared 8 May 1997

• National Medical Halthcare Custom Ophthalmic Kits or Trays

  Class I

  FDA 510(k) K971465 Active Cleared 4 Jun 1997

• What clinical settings is the NHMC Urethral Catheterization Tray designed for, and why is this important?

  The NHMC Urethral Catheterization Tray is specifically designed for use in clinical settings like hospitals and medical offices where sterile conditions are maintained. This is important because the tray is sterile and single-use, ensuring patient safety and reducing the risk of infection during urethral catheterization procedures. The sterile packaging and aseptic components are critical for maintaining hygiene standards in these controlled environments.

• Is the NHMC Urethral Catheterization Tray reusable, and if not, how should it be disposed of?

  No, the NHMC Urethral Catheterization Tray is explicitly designed for single-use only. Since it is sterile and intended for one-time use, it must be discarded after a single procedure to prevent contamination and maintain infection control. Follow local healthcare facility protocols for proper disposal of single-use medical devices.

• What types of catheters and supplies are included in the tray, and how does this support the procedure?

  While the exact catheter sizes or specific supplies aren’t detailed in the data, the tray is classified as a sterile urethral catheterization kit, meaning it includes essential components like catheters, lubricants, and sterile drapes or accessories to facilitate safe and aseptic insertion and drainage of urine. This setup ensures all necessary tools are available in a sterile package, reducing the need for additional supplies and minimizing procedural risks.

• How should the NHMC Urethral Catheterization Tray be stored to ensure sterility and functionality?

  The tray must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is sterile and single-use, it should be kept in its original, unopened packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Avoid storing it in areas prone to moisture or dust, as this could compromise its integrity before use.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical practice?

  The NHMC Urethral Catheterization Tray was cleared through the FDA 510(k) process (K962254), specifically under the classification of Class II medical devices. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards. Clinically, this clearance indicates the device has undergone review by the FDA for compliance with regulations, though final use decisions should align with local healthcare protocols and professional guidelines.