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
- K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)2Cleared 510(K)
- K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)2Cleared 510(K)
- K232632Racz Neurostat RF Generator2Cleared 510(K)
- K231675OneRF Ablation System2Cleared 510(K)
- K220122APEX 62Cleared 510(K)
- K203293Abbott Medical Grounding Pad, model RF-DGP-IS2Cleared 510(K)
- K201610IonicRF Generator2Cleared 510(K)
- K192491Coolief Radiofrequency Generator (CRG) System2Cleared 510(K)
- K181864Polaris RF Ablation System2Cleared 510(K)
- K171143Relievant Medsystems RF Generator2Cleared 510(K)
- K170242MultiGen™ 2 RF Generator System2Cleared 510(K)
- K101592ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM2Cleared 510(K)
- K111576NT 2000 LESIONING GENERATOR2Cleared 510(K)
- K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)2Cleared 510(K)
- K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-42Cleared 510(K)
- K081729MODIFICATION TO GFX NERVE ABLATION SYSTEM2Cleared 510(K)
- K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-0002Cleared 510(K)
- K063753GFX NERVE ABLATION SYSTEM2Cleared 510(K)
- K070336STOCKERT NEURO N50, MODEL122672Cleared 510(K)
- K063489STRYKER INTRADISCAL RF GENERATOR2Cleared 510(K)
- K062758OWL URF-3AP2Cleared 510(K)
- K052878NT-10002Cleared 510(K)
- K040565PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE2Cleared 510(K)
- K032601STRYKER INTERVENTIONAL PAIN RF GENERATOR2Cleared 510(K)
- K021869OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP2Cleared 510(K)
- K020354BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)2Cleared 510(K)
- K010202OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES2Cleared 510(K)
- K002565BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)2Cleared 510(K)
- K010969NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES2Cleared 510(K)
- K983214RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES2Cleared 510(K)
- K982489RFG-3C PLUS2Cleared 510(K)
- K965182RFG-3CF2Cleared 510(K)
- K963577RADIONICS SLUIJTER-MEHTA CANNULA2Cleared 510(K)
- K941823LEKSELL NEURO GENERATOR AND ACCESSORIES2Cleared 510(K)
- K922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE2Cleared 510(K)
- K901540MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR2Cleared 510(K)
- K896450NEURO N 50 LESION GENERATOR2Cleared 510(K)
- GXELeukotome1Product Code
- GXHDevice, Surgical, Cryogenic2Product Code
- GXIProbe, Radiofrequency Lesion2Product Code
- 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
MODIFICATION TO GFX NERVE ABLATION SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K081729
- 510(k) Type
- Special
- Applicant
- BIOFORM MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/7/2008
- Days to Decision
- 50 days
- Submission Type
- Summary