510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983214Unknown

Rita RF Generator and Accessories, Model 500 Series

Boston Scientific Corporation, Mountain View CA / Traditional, Unknown
FDA source (opens on fda.gov)

K983214 is the FDA 510(k) clearance record for RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES, a class II device, cleared for Rita Medical Systems on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K983214.

Clearance record

Decision date
Received
(560 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Rita Medical Systems 967 N. Shoreline Blvd., Mountain View CA
510(k) summary
Summary
Third party review
No

Clearances, product code GXD

Trailing 12 months

FDA records hold no clearances under product code GXD in the trailing twelve months.

FDA records show no clearances under product code GXD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260