Convenience Contour Kits Redi Nurse System

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

510(k) Number

K933151 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SEKD

• Redi Nurse System (Rns) Pre-Filled 60cc Irrigation Syringe W/Sterile Sodium Chloride Solution

  Class I

  FDA 510(k) K952406 Active Cleared 7 Aug 1995

• Rns Sterile, Disposable CT Biopsy Tray

  Class II

  FDA 510(k) K955685 Active Cleared 4 Oct 1996

• Rns Sterile Disposable Puncture Tray

  Class II

  FDA 510(k) K955678 Active Cleared 21 Feb 1996

• Rns Sterile, Disposable Breast Biopsy/Localization Tray

  Class I

  FDA 510(k) K955683 Active Cleared 1 Feb 1996

• Ready Nurse System (Rns) Trach Care Kit

  Class I

  FDA 510(k) K952925 Active Cleared 12 Jul 1995

• Rns, Sterile Disposable Percutaneous Cholangiographic Tray

  Class II

  FDA 510(k) K955686 Active Cleared 21 Feb 1996

See all devices from Contour Fabricators of Florida, Inc. →

• What is the Convenience Contour Kits Redi Nurse System used for?

  The Redi Nurse System is a modular nursing accessory kit engineered to streamline patient care tasks such as positioning, support, and mobility in general hospital settings. Its pre-assembled, customizable components are intended to minimize setup time for nurses, improving efficiency during patient handling.

• Is the Redi Nurse System reusable or single-use?

  The Redi Nurse System is designed as a reusable device. It is not intended for single-use and requires cleaning and maintenance between uses to ensure proper functionality and hygiene.

• Does the Redi Nurse System come sterile?

  No, the Redi Nurse System is not supplied sterile. It is intended for reusable use in hospital environments, meaning it must be cleaned and maintained between patient interactions to prevent contamination.

• What regulatory pathway does the Redi Nurse System follow?

  The Convenience Contour Kits Redi Nurse System is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K933151. It falls under product code FRG and is classified under 21 CFR 876.5130.

• How does the modular design of the Redi Nurse System benefit nurses?

  The modular design of the Redi Nurse System allows for pre-contoured and ready-to-use components, which significantly reduces the time nurses spend assembling equipment for patient care. This customizable setup enhances workflow efficiency, particularly in tasks requiring positioning, support, or mobility assistance.