MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA— 510(k) K000073

Clearance details

Applicant

Mercury Medical

Product code

Code GXI

Device class

Class 2

Regulation

21 CFR 882.4725

Advisory panel

Neurology

Date received

2000-01-10

Decision date

2000-03-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Middleton, MA, US

• K253907 — Disposable Radiofrequency Cannula2026-04-16
• K251802 — STAR RF Ablation System2026-02-13
• K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
• K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
• K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

• K142096 — T-PIECE RESUSCITATOR2014-10-17
• K090710 — MERCURY CPAP2009-08-20
• K083056 — NEO-STAT CO2 <KG2009-02-23
• K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER2004-02-03
• K031814 — STATCO2METER, MODEL 10-553722003-08-14

Death

3

Injury

171

Total

174

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-1247-2016 — Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.Class II·Terminated·Neurotherm, Inc.·20130226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000073.