Anesthesiology
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- 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
- 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
- K242759Geister K-Rex rongeurs2Cleared 510(K)
- K223596SQ.line KERRISON2Cleared 510(K)
- K230256Rebellion, Phantom Multi-Bite Kerrison Rongeur2Cleared 510(K)
- K221818Rebellion; Phantom Multi-Bite Kerrison Rongeur2Cleared 510(K)
- K210741KLS Martin Neuro Rongeurs2Cleared 510(K)
- K200768Rebellion, Phantom Multi-Bite Kerrison Rongeur2Cleared 510(K)
- K200387Ace Medical Surgical Instruments2Cleared 510(K)
- K200383Wiggins Medical Surgical Instruments2Cleared 510(K)
- K180949Steribite2Cleared 510(K)
- K161744Symmetry Sharp Kerrison Rongeur2Cleared 510(K)
- K153243Fehling-Punches2Cleared 510(K)
- K152734Kerrison Rongeurs2Cleared 510(K)
- K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs2Cleared 510(K)
- K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs2Cleared 510(K)
- K131851OSTEOMED NEURO RONGEUR2Cleared 510(K)
- K130541SYMMETRY KERRISON DISPOSABLE TIP RONGEURS2Cleared 510(K)
- K113073IO-TOME DEVICE2Cleared 510(K)
- K113533NEURO CHECK DEVICE WITH IO-FLEX WIRE2Cleared 510(K)
- K100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES2Cleared 510(K)
- K092227JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS2Cleared 510(K)
- K081651INSTRUMED RONGEUR2Cleared 510(K)
- K080494BAXANO ULTRA LOW PROFILE RONGEUR2Cleared 510(K)
- K063231MICROBLADE SHAVER AND ACCESSORIES2Cleared 510(K)
- K062711ULTRA LOW PROFILE RONGEUR2Cleared 510(K)
- K023868DAN KERRISON RONGEURS, MODELS K1 + BILLY 12Cleared 510(K)
- K954699BRAY RONGEUR2Cleared 510(K)
- K943583KERRISON RONGEURS2Cleared 510(K)
- K943635ULTRA-LINE RONGEUR2Cleared 510(K)
- K943116AUTO SUTURE KERRISON SPINAL RONGEUR2Cleared 510(K)
- K933978NEDBOND EJECTOR KERRISON RONGEUR2Cleared 510(K)
- K903151INTERVERTEBRAL DISC RONGEUR2Cleared 510(K)
- K903401SPECIAL RONGEUR2Cleared 510(K)
- K901313INSTRUMENTS FOR NEUROLOGICAL SURGERY2Cleared 510(K)
- K901372LAMINECTOMY RONGEUR2Cleared 510(K)
- K892535NEUROLOGICAL RONGEURS - VARIOUS TYPES2Cleared 510(K)
- K875043RONGEUR (NEUROSURGICAL INSTRUMENTS)2Cleared 510(K)
- 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
NEURO CHECK DEVICE WITH IO-FLEX WIRE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K113533
- 510(k) Type
- Special
- Applicant
- Baxano, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/11/2012
- Days to Decision
- 133 days
- Submission Type
- Summary