RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES— 510(k) K983214

Name: FDA 510(k) clearance K983214
Creator: U.S. Food and Drug Administration
Published: 2000-03-27

Unknown

Rita Medical Systems

FDA 510(k) clearance K983214 for RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES, Unknown on 2000-03-27. Applicant: Rita Medical Systems. Device class: 2.

Clearance details

Applicant: Rita Medical Systems
Product code: Code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 1998-09-14
Decision date: 2000-03-27
Decision: Unknown
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXD

view all

K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V) +6 more2025-08-07
K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)2024-08-14
K232632 — Racz Neurostat RF Generator2024-05-24
K231675 — OneRF Ablation System2023-12-06
K220122 — APEX 62023-03-15

More clearances from Rita Medical Systems

view all

K062935 — HABIB 4X LAPAROSCOPIC2006-10-13
K040989 — RITA SYSTEMS2004-04-28
K030967 — RITA STARBURST SDE ELECTROSURGICAL DEVICE2003-04-21
K023846 — MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY2002-12-06
K021329 — RITA SYSTEM2002-10-09

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.