ClearanceBrief
Panels › Neurology › Product code GXI · Class 2

Probe, Radiofrequency Lesion

Regulation 882.4725

2510(k)s in 12 months (66 all time)
3recalls in 12 months (29 all time)
29recalls that name a 510(k)
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Top companies in GXI

DateFirm and productCodeLinked 510(k)
Jul 8, 2026Boston Scientific Neuromodulation Corporation
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCE
Open, Classified
GXIK222281
Jun 11, 2026Boston Scientific Neuromodulation Corporation
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15
Open, Classified
GXIK050084
K183177
Jun 11, 2026Boston Scientific Neuromodulation Corporation
Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC
Open, Classified
GXIK050084
K183177
Jul 3, 2024Stryker Corporation
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then ins
Open, Classified
GXIK032406
Jun 8, 2020Medtronic Sofamor Danek USA Inc
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an
Terminated
GXIK181864
Jun 8, 2020Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an a
Terminated
GXIK181864
Jun 8, 2020Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an
Terminated
GXIK181864
Jun 8, 2020Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an
Terminated
GXIK181864
Jun 8, 2020Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an
Terminated
GXIK181864
Apr 16, 2020Epimed International
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofreque
Terminated
GXIK041021
Apr 16, 2020Epimed International
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequ
Terminated
GXIK041021
Apr 10, 2020Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensi
Terminated
GXIK183177
Apr 10, 2020Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are tempe
Terminated
GXIK183177
Apr 10, 2020Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sen
Terminated
GXIK183177
Apr 10, 2020Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are tempe
Terminated
GXIK183177
Apr 10, 2020Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sen
Terminated
GXIK183177
Nov 11, 2019Abbott Medical
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geom
Terminated
GXIK090955
Jul 5, 2017Cosman Medical, LLC
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12)
Terminated
GXIK050084
Jun 16, 2016Halyard Health, Inc
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Terminated
GXIK053082
Mar 24, 2016Neurotherm, Inc.
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 radiofreq
Terminated
GXIK000073
Jan 28, 2014Kimberly-Clark Corporation
Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in
Terminated
GXIK972846
Feb 26, 2013Baylis Medical Company Inc.
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white she
Terminated
GXIK972846
Aug 2, 2012Stryker Instruments Div. of Stryker Corporation
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes,
Terminated
GXIK032406
Aug 2, 2012Stryker Instruments Div. of Stryker Corporation
RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, a
Terminated
GXIK032406
Jun 3, 2010Baylis Medical Corp *
The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-1
Terminated
GXIK053082
K062937
Jan 13, 2009Neurotherm, Inc.
NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
Terminated
GXIK011387
Mar 29, 2007Smith & Nephew, Inc. Endoscopy Division
RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210272
Terminated
GXIK034012
Mar 29, 2007Smith & Nephew, Inc. Endoscopy Division
RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271
Terminated
GXIK034012
Mar 29, 2007Smith & Nephew, Inc. Endoscopy Division
RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270
Terminated
GXIK034012

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