Rita System

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

510(k) Number

K021329 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Vortex Ez Vascular Access Port

  Class II

  FDA 510(k) K050176 Active Cleared 25 Feb 2005

• Omnipicc Pi

  Class II

  FDA 510(k) K051102 Active Cleared 23 Nov 2005

• Rita Rf Generator and Accessories, Model 500 Series

  Class II

  FDA 510(k) K983214 Active Cleared 27 Mar 2000

• Rita Model 1500X Electrosurgical Rf Generator

  Class II

  FDA 510(k) K031257 Active Cleared 2 May 2003

• Omnipicc P.I.

  Class II

  FDA 510(k) K062579 Active Cleared 28 Nov 2006

• Vortex CT Port Access System and Lifeguard Safety Infusion Set

  Class II

  FDA 510(k) K062414 Active Cleared 1 Feb 2007

See all devices from Rita Medical Systems, Inc. →

• What is the Rita System used for?

  The Rita System is a radiofrequency ablation device used for the minimally invasive treatment of solid tumors, both cancerous and benign. It delivers controlled radiofrequency energy to coagulate and destroy targeted tissue, providing a precise alternative to surgical excision. It is intended for use by trained medical professionals in clinical settings where MRI safety is not a concern.

• How is the Rita System supplied and is it reusable?

  The Rita System is supplied sterile and is designed for single-use only. It is not intended for reuse, reprocessing, or resterilization. Each unit is provided as a sterile, single-use device to ensure patient safety and maintain the integrity of the ablation components, in accordance with standard sterile medical device protocols.

• What regulatory pathway was used for the Rita System’s authorization?

  The Rita System was authorized under the FDA 510(k) clearance pathway, specifically under submission K021329, which was granted on October 9, 2002. The clearance was based on a determination of substantial equivalence to a predicate device, and the device is classified under product code GEI for General, Plastic Surgery applications.

• What are the storage and handling requirements for the Rita System?

  The Rita System must be stored and handled according to standard sterile medical device protocols as outlined in the manufacturer’s instructions. This includes maintaining the integrity of the sterile packaging until use, storing in a clean, dry environment at controlled room temperature, and avoiding exposure to moisture, extreme temperatures, or physical damage that could compromise sterility or functionality.