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MR Compatible Rita Model 90 Electosurgical Accessory

by Rita Medical Systems

510(k) K023846

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK023846 Date6 Dec 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. The MR Compatible Rita Model 90 Electrosurgical Accessory is designed to supply energy generated by the Rita Medical Systems' Electrosurgical Generator for use in electrosurgery.

It incorporates multiple needles on each probe to minimize the number of invasive accesses necessary to achieve desired lesions. The device is supplied as a single-use accessory and is MRI compatible. It received FDA 510(k) clearance under K023846 with product code GEI and is classified under the General, Plastic Surgery advisory committee.

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