Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- GXDGenerator, Lesion, Radiofrequency2Product Code
- GXELeukotome1Product Code
- GXHDevice, Surgical, Cryogenic2Product Code
- GXIProbe, Radiofrequency Lesion2Product Code
- K251243OneRF Trigeminal Nerve Radiofrequency Probes2Cleared 510(K)
- K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2Cleared 510(K)
- K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)2Cleared 510(K)
- K241367RF Cannula2Cleared 510(K)
- K222281Intracept Intraosseous Nerve Ablation System2Cleared 510(K)
- K213836Intracept Intraosseous Nerve Ablation System2Cleared 510(K)
- K203066COOLIEF Cooled Radiofrequency Kit Advanced2Cleared 510(K)
- K190259Vesta RF Cannula2Cleared 510(K)
- K191293LCCS VC-S RF Cannula2Cleared 510(K)
- K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator2Cleared 510(K)
- K190256Rulo Radiofrequency Lesion Probe2Cleared 510(K)
- K183177Nitinol Thermocouple (TCN) Electrode2Cleared 510(K)
- K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)2Cleared 510(K)
- K170827INTRACEPT Intraosseous Nerve Ablation System2Cleared 510(K)
- K170708OWL RF INSULATED CANNULAE2Cleared 510(K)
- K163461Coolief* Cooled RF Probe2Cleared 510(K)
- K163236COOLIEF Cooled Radiofrequency Kit2Cleared 510(K)
- K152642LCCS Disposable RF Electrode, LCCS Reusable RF Electrode2Cleared 510(K)
- K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set2Cleared 510(K)
- K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH2Cleared 510(K)
- K141586OWL CANNULAE2Cleared 510(K)
- K123178STRYKER VENOM ELECTRODES AND CANNULAE2Cleared 510(K)
- K121773NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE2Cleared 510(K)
- K112231LCCS INSULATED SPINAL NEEDLE (RF CANNULA)2Cleared 510(K)
- K102566OWL CANNULAE2Cleared 510(K)
- K110593OWL RF PROBES2Cleared 510(K)
- K101372DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-202Cleared 510(K)
- K090608MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)2Cleared 510(K)
- K092337PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS2Cleared 510(K)
- K090955SMITH & NEPHEW RF CANNULATE2Cleared 510(K)
- K080771TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC2Cleared 510(K)
- K082012COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN2Cleared 510(K)
- K071300MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE2Cleared 510(K)
- K071745BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE2Cleared 510(K)
- K062946TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL2Cleared 510(K)
- K062937TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU2Cleared 510(K)
- K063467SMITH & NEPHEW RF CANNULAE2Cleared 510(K)
- K060397RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED2Cleared 510(K)
- K060799COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA2Cleared 510(K)
- K053415LESIONPOINT RF CANNULA2Cleared 510(K)
- K053082BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-62Cleared 510(K)
- K043442STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE2Cleared 510(K)
- K050084COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;2Cleared 510(K)
- K042375SMK, CX, CXE, RCN2Cleared 510(K)
- K041021RF INTRODUCTION CANNULA2Cleared 510(K)
- K032406STRYKER RF ELECTRODES AND CANNULAE2Cleared 510(K)
- K034012SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE2Cleared 510(K)
- K032196NBD DISPOSABLE RF CANNULAE2Cleared 510(K)
- K021942RADIONICS POLE NEEDLES2Cleared 510(K)
- K011387NEUROTHERM, MODEL JK42Cleared 510(K)
- K002389BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY2Cleared 510(K)
- K001588ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 202Cleared 510(K)
- K994344NEUROTHERM RF CANNULA2Cleared 510(K)
- K000073MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA2Cleared 510(K)
- K991399RADIONICS MICROELECTRODE KIT2Cleared 510(K)
- K972846BMC RF CANNULA2Cleared 510(K)
- K980430RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)2Cleared 510(K)
- K884347MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN2Cleared 510(K)
- K882802STORZ DISPOSABLE BIPOLAR PENCILS2Cleared 510(K)
- K880951DISPOSABLE COAXIAL BIPOLAR PEN P/N 001502Cleared 510(K)
- K880925DISPOSABLE WET FIELD ERASER2Cleared 510(K)
- K880293THE STORZ BIPOLAR PENCIL AND CORD2Cleared 510(K)
- K870028SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE2Cleared 510(K)
- K802243VAXIOM FAMILY OF RF LESION PROBES & ELEC2Cleared 510(K)
- GXJPunch, Skull1Product Code
- GXLScrewdriver, Skullplate1Product Code
- GXMAnvil, Skull Plate1Product Code
- GYKInstrument, Shunt System Implantation1Product Code
- GZQInstrument, Dowel Cutting2Product Code
- GZTRetractor, Self-Retaining, For Neurosurgery2Product Code
- GZXInstrument, Microsurgical1Product Code
- HADRongeur, Powered2Product Code
- HAERongeur, Manual2Product Code
- HAOInstrument, Surgical, Non-Powered1Product Code
- HASNeedle, Neurosurgical Suture1Product Code
- HAWNeurological Stereotaxic Instrument2Product Code
- HBANeurosurgical Paddie2Product Code
- HBBMotor, Drill, Pneumatic2Product Code
- HBCMotor, Drill, Electric2Product Code
- HBDHandpiece (Brace), Drill1Product Code
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2Product Code
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)2Product Code
- HBGDrills, Burrs, Trephines & Accessories (Manual)2Product Code
- HBLHolder, Head, Neurosurgical (Skull Clamp)2Product Code
- HBMHeadrest, Neurosurgical1Product Code
- HBNChair, Neurosurgical1Product Code
- HBOClip, Scalp2Product Code
- HBQInstrument, Clip Removal1Product Code
- HBRRack, Clip1Product Code
- HBSInstrument, Clip Forming/Cutting1Product Code
- HBXInstrument, Cranioplasty Material Forming1Product Code
- HCACatheter, Ventricular2Product Code
- HCDCannula, Ventricular1Product Code
- HCIApplier, Aneurysm Clip2Product Code
- NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)2Product Code
- NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed2Product Code
- NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed2Product Code
- NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed2Product Code
- NMNInstrument, Clip, Forming/Cutting, Reprocessed1Product Code
- OJGNeurological Tray1Product Code
- ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri2Product Code
- PIYStainless Steel Instrument, Shunt System Implantation1Product Code
- PPTCranial Surgical Planning And Instrument Guides2Product Code
- PVMEndoscopic Ventricular Catheter Placement Kit2Product Code
- QFXDiagnostic Neurosurgical Microscope Filter2Product Code
- QRISurgical Planning Software For Neurological Stereotaxic Instruments2Product Code
- SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
COOLIEF Cooled Radiofrequency Kit
- Page Type
- Cleared 510(K)
- 510(k) Number
- K163236
- 510(k) Type
- Traditional
- Applicant
- Halyard Health, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/16/2016
- Days to Decision
- 29 days
- Submission Type
- Summary