Rita Systems

• • Terminated Z-1675-2013 FDA Class II ·initiated 11 Jun 2013

  The RITA Main Cable product contains the incorrect Instructions for Use.

510(k) Number

K040989 ↗

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

• Rita System

  Class II

  FDA 510(k) K021329 Active Cleared 9 Oct 2002

• Omnipicc P.I.

  Class II

  FDA 510(k) K062579 Active Cleared 28 Nov 2006

See all devices from Rita Medical Systems, Inc. →

• What clinical purpose does the RITA SYSTEMS serve?

  The RITA SYSTEMS is designed to treat cancer by delivering radio‑frequency energy that creates thermal ablation of tumor tissue. This method is used in oncology therapy to destroy malignant cells while sparing surrounding healthy structures.

• How is the RITA SYSTEMS supplied and are there different models or sizes?

  Rita Medical Systems supplies the RITA SYSTEMS as a complete radio‑frequency unit. The manufacturer specifies particular model numbers and sizes, though the exact variants are not listed in the data. Clinicians select the appropriate configuration based on the surgical setting and tumor characteristics.

• Is the RITA SYSTEMS a sterile, single‑use product or can it be reused?

  The device description does not state sterility or single‑use status. Because it is a radio‑frequency system intended for use in operating rooms, it is typically provided as a reusable unit that must be sterilized according to the manufacturer’s instructions before each procedure.

• What regulatory clearance does the RITA SYSTEMS have?

  The RITA SYSTEMS received FDA 510(k) clearance (K040989) with a traditional clearance pathway, indicating it is substantially equivalent to a legally marketed predicate device. The clearance was granted on April 28, 2004.