Product code GXI— Neurology
Intracept Intraosseous Nerve Ablation System
- Classification name
- Probe, Radiofrequency Lesion
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Total cleared
- 66
- First cleared
- Most recent
Market context for product code GXI
FDA has cleared devices under product code GXI between 1980 and 2026, filed by 32 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
Top applicants under product code GXI
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GXI
- K253907 — Disposable Radiofrequency Cannula
- K251802 — STAR RF Ablation System
- K251243 — OneRF Trigeminal Nerve Radiofrequency Probes
- K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
- K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more
- K241367 — RF Cannula
- K222281 — Intracept Intraosseous Nerve Ablation System
- K213836 — Intracept Intraosseous Nerve Ablation System
- K203066 — COOLIEF Cooled Radiofrequency Kit Advanced
- K190259 — Vesta RF Cannula
- K191293 — LCCS VC-S RF Cannula
- K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
- K183177 — Nitinol Thermocouple (TCN) Electrode
- K190256 — Rulo Radiofrequency Lesion Probe
- K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
- K170827 — INTRACEPT Intraosseous Nerve Ablation System
- K170708 — OWL RF INSULATED CANNULAE
- K163461 — Coolief* Cooled RF Probe
- K163236 — COOLIEF Cooled Radiofrequency Kit
- K152642 — LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
- K153272 — INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
- K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
- K141586 — OWL CANNULAE
- K123178 — STRYKER VENOM ELECTRODES AND CANNULAE
- K121773 — NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
- K112231 — LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
- K102566 — OWL CANNULAE
- K110593 — OWL RF PROBES
- K101372 — DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
- K090608 — MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
- K092337 — PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
- K090955 — SMITH & NEPHEW RF CANNULATE
- K080771 — TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
- K082012 — COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
- K071300 — MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
- K071745 — BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
- K062946 — TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
- K062937 — TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
- K063467 — SMITH & NEPHEW RF CANNULAE
- K060397 — RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
- K060799 — COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
- K053415 — LESIONPOINT RF CANNULA
- K053082 — BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
- K043442 — STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
- K050084 — COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT
- K042375 — SMK, CX, CXE, RCN
- K041021 — RF INTRODUCTION CANNULA
- K032406 — STRYKER RF ELECTRODES AND CANNULAE
- K034012 — SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
- K032196 — NBD DISPOSABLE RF CANNULAE
- K021942 — RADIONICS POLE NEEDLES
- K011387 — NEUROTHERM, MODEL JK4
- K002389 — BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
- K001588 — ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
- K994344 — NEUROTHERM RF CANNULA
- K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
- K991399 — RADIONICS MICROELECTRODE KIT
- K972846 — BMC RF CANNULA
- K980430 — RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
- K884347 — MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
- K882802 — STORZ DISPOSABLE BIPOLAR PENCILS
- K880925 — DISPOSABLE WET FIELD ERASER
- K880951 — DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
- K880293 — THE STORZ BIPOLAR PENCIL AND CORD
- K870028 — SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
- K802243 — VAXIOM FAMILY OF RF LESION PROBES & ELEC
Data sourced from openFDA. This site is unofficial and independent of the FDA.