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)
Top companies in GXI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2026 | Boston 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 |
GXI | K222281 |
| Jun 11, 2026 | Boston 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 |
GXI | K050084 K183177 |
| Jun 11, 2026 | Boston 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 |
GXI | K050084 K183177 |
| Jul 3, 2024 | Stryker 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 |
GXI | K032406 |
| Jun 8, 2020 | Medtronic 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 |
GXI | K181864 |
| Jun 8, 2020 | Medtronic 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 |
GXI | K181864 |
| Jun 8, 2020 | Medtronic 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 |
GXI | K181864 |
| Jun 8, 2020 | Medtronic 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 |
GXI | K181864 |
| Jun 8, 2020 | Medtronic 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 |
GXI | K181864 |
| Apr 16, 2020 | Epimed 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 |
GXI | K041021 |
| Apr 16, 2020 | Epimed 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 |
GXI | K041021 |
| Apr 10, 2020 | Boston 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 |
GXI | K183177 |
| Apr 10, 2020 | Boston 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 |
GXI | K183177 |
| Apr 10, 2020 | Boston 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 |
GXI | K183177 |
| Apr 10, 2020 | Boston 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 |
GXI | K183177 |
| Apr 10, 2020 | Boston 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 |
GXI | K183177 |
| Nov 11, 2019 | Abbott 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 |
GXI | K090955 |
| Jul 5, 2017 | Cosman 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 |
GXI | K050084 |
| Jun 16, 2016 | Halyard 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 |
GXI | K053082 |
| Mar 24, 2016 | Neurotherm, 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 |
GXI | K000073 |
| Jan 28, 2014 | Kimberly-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 |
GXI | K972846 |
| Feb 26, 2013 | Baylis 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 |
GXI | K972846 |
| Aug 2, 2012 | Stryker 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 |
GXI | K032406 |
| Aug 2, 2012 | Stryker 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 |
GXI | K032406 |
| Jun 3, 2010 | Baylis 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 |
GXI | K053082 K062937 |
| Jan 13, 2009 | Neurotherm, Inc. NeuroTherm Simplicity III RF Electrode
Model Number: RFDE-SI
The lesioning of neural tissue. Terminated |
GXI | K011387 |
| Mar 29, 2007 | Smith & 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 |
GXI | K034012 |
| Mar 29, 2007 | Smith & 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 |
GXI | K034012 |
| Mar 29, 2007 | Smith & 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 |
GXI | K034012 |
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