LEVEEN NEEDLE ELECTRODE— 510(k) K982556

Clearance details

Applicant

Radiotherapeutics Corp.

Product code

Code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

1998-07-22

Decision date

2000-04-06

Decision

Unknown

Clearance type

Traditional

Location

Mountain View, CA, US

• K254185 — Potenza Prime2026-09-11
• K262364 — Ellian Enigma RF Device2026-09-02
• K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
• K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
• K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

• K011220 — LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE2002-07-01
• K012315 — LEVEEN ELECTRODE2001-10-11
• K000241 — RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR2000-04-14
• K000032 — LEVEEN NEEDLE ELECTRODE2000-03-30
• K982854 — MR COMPATIBLE LEVEEN NEEDLE ELECTRODE1998-11-10

Death

133

Injury

7,585

Malfunction

35,808

Other

44

Total

43,570

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 →

• Z-0079-2013 — LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.Class II·Terminated·Boston Scientific Corporation·20120917

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982556.