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
- GXWEchoencephalograph2Product Code
- GXXBlock, Test, Ultrasonic Scanner Calibration1Product Code
- GXYElectrode, Cutaneous2Product Code
- GXZElectrode, Needle2Product Code
- GYATester, Electrode/Lead, Electroencephalograph1Product Code
- GXSMonitor, Alpha2Product Code
- GWEStimulator, Photic, Evoked Response2Product Code
- GWFStimulator, Electrical, Evoked Response2Product Code
- GWGEndoscope, Neurological2Product Code
- K243429HJY VisualNext 3D Endoscopic Vision System2Cleared 510(K)
- K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)2Cleared 510(K)
- K233391cCeLL - In vivo2Cleared 510(K)
- K223615Digital ClarusScope System, Digital NeuroPEN System2Cleared 510(K)
- K232618Aurora Surgiscope System2Cleared 510(K)
- K230125Neuroblade System2Cleared 510(K)
- K232159QEVO System2Cleared 510(K)
- K222735HJY VisualNext Endoscopic Vision System2Cleared 510(K)
- K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes2Cleared 510(K)
- K210251ClearPath Disposable Introducer2Cleared 510(K)
- K200925Clarus Peel-Away Introducer Sheath2Cleared 510(K)
- K201308Axonpen, Axonmonitor, Axonbox, Tablet2Cleared 510(K)
- K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)2Cleared 510(K)
- K191861Aurora Surgiscope System2Cleared 510(K)
- K190719Artemis Eye System2Cleared 510(K)
- K182211Aurora Surgiscope System2Cleared 510(K)
- K181731MR Compatible Aspiration Kit2Cleared 510(K)
- K181116CONVIVO2Cleared 510(K)
- K180270Cellvizio 100 Series Systems with Confocal Miniprobes2Cleared 510(K)
- K180146KARL STORZ ICG Imaging System2Cleared 510(K)
- K170667QEVO System with KINEVO 9002Cleared 510(K)
- K171332Artemis Neuro Evacuation Device2Cleared 510(K)
- K170462KARL STORZ ShuntScope2Cleared 510(K)
- K162880TIPCAM 1S 3D System2Cleared 510(K)
- K161112KARL STORZ Flexible Video-Neuro-Endoscope System2Cleared 510(K)
- K152699Apollo System2Cleared 510(K)
- K142315MINOP Disposable Introducer 26F2Cleared 510(K)
- K132931APOLLO SYSTEM2Cleared 510(K)
- K131434VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM2Cleared 510(K)
- K081102VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM2Cleared 510(K)
- K072410KSEA CLEARVISION II, MODEL 403341202Cleared 510(K)
- K061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME0192Cleared 510(K)
- K052745ASSISTO ARM SYSTEMS2Cleared 510(K)
- K043128OLYMPUS ENDOARM2Cleared 510(K)
- K031858NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES2Cleared 510(K)
- K022198ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.4522Cleared 510(K)
- K020507OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/42Cleared 510(K)
- K013759MSS-28CS-301/701 NEEDLESCOPE2Cleared 510(K)
- K021050KSEA NEUROENDOSCOPES AND ACCESSORIES2Cleared 510(K)
- K014149PAEDISCOPE, MODEL # P010A AND PF011A2Cleared 510(K)
- K010341MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,2Cleared 510(K)
- K003914MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES2Cleared 510(K)
- K002572MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-0052Cleared 510(K)
- K002704KSEA MINIATURE NEUROENDOSCOPE2Cleared 510(K)
- K002788KSEA NEURO-FIBERSCOPE2Cleared 510(K)
- K002330NAVIGUS PEEL AWAY INTRODUCER2Cleared 510(K)
- K001630KSEA BIPOLAR COAGULATING ELECTRODES2Cleared 510(K)
- K993568MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L2Cleared 510(K)
- K993539DCI ENDOSCOPE2Cleared 510(K)
- K991989MITAKA POINT SETTER2Cleared 510(K)
- K991069KSEA NEURO-FIBERSCOPE2Cleared 510(K)
- K990333MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-0152Cleared 510(K)
- K982819ENDIUS SPINE ENDOSCOPE2Cleared 510(K)
- K983365AESCULAP MINOP SYSTEM2Cleared 510(K)
- K982837KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS2Cleared 510(K)
- K971340OLYMPUS NEURO ENDOSCOPE2Cleared 510(K)
- K963642INCL II ENDOSCOPE2Cleared 510(K)
- K970162NEUROLOGICAL ENDOSCOPE2Cleared 510(K)
- K964281AESCULAP ANGLED NEUROENDOSCOPES2Cleared 510(K)
- K9650782.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS2Cleared 510(K)
- K960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX2Cleared 510(K)
- K961406NEUROVIEW SCISSORS2Cleared 510(K)
- K961300ASPIRATION/IRRIGATION CATHETER2Cleared 510(K)
- K9611731.2MM REUSABLE NEUROVIEW ENDOSCOPE2Cleared 510(K)
- K960792DISPOSABLE NEUROVIEW INTRODUCER SHEATH2Cleared 510(K)
- K954938DISPOSABLE NEUROVIEW OPERATING SHEATH2Cleared 510(K)
- K954394AESCULAP VENTRICULOSCOPE SYSTEM2Cleared 510(K)
- K955351NEUROVIEW COAXIAL BIPOLAR ELECTRODE2Cleared 510(K)
- K955598CLARUS SPINEPEN MODEL 21262Cleared 510(K)
- K954899RIGID NEUROVIEW ENDOSCOPE2Cleared 510(K)
- K953554NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES2Cleared 510(K)
- K953685INSTRUMENT SCOPE2Cleared 510(K)
- K953173NONPOWERED NEUROSURGICAL INSTRUMENT2Cleared 510(K)
- K945633NEURO CHANNEL ENDOSCOPE MODEL 22322Cleared 510(K)
- K9501541.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES2Cleared 510(K)
- K945296CLARUS PHOENIX NEURO ENDOSCOPE MODEL 21602Cleared 510(K)
- K940273NOBLES-LAI VIDEO IMAGING SYSTEM2Cleared 510(K)
- K934154DISPOSABLE ASPIRATION/IRRIGATION CATHETER2Cleared 510(K)
- K945572CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-13522Cleared 510(K)
- K942413CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR2Cleared 510(K)
- K942249CLARUS NEUROPEN MODEL 21202Cleared 510(K)
- K942955DISPOSABLE BIPOLAR ELECTRODE2Cleared 510(K)
- K941239AESCULAP NEUROENDOSCOPE2Cleared 510(K)
- K940096PS MEDICAL CATHETER PLACEMENT KIT2Cleared 510(K)
- K934196CODMAN QUICK SHUNT KIT, CAT. #82-65702Cleared 510(K)
- K924977CODMAN LASER NEUROENDOSCOPE2Cleared 510(K)
- K931973DISPOSABLE PEEL-AWAY INTRODUCER SHEATH2Cleared 510(K)
- K933244DISPOSABLE GRASPING FORCEP2Cleared 510(K)
- K925881DISPOSABLE BIOPSY FORCEP2Cleared 510(K)
- K923479DISPOSABLE NEUROVIEW ENDOSCOPE2Cleared 510(K)
- K923646CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS2Cleared 510(K)
- GWIDiscriminator, Two-Point1Product Code
- GWJStimulator, Auditory, Evoked Response2Product Code
- GWKConditioner, Signal, Physiological2Product Code
- GWLAmplifier, Physiological Signal2Product Code
- GWMDevice, Monitoring, Intracranial Pressure2Product Code
- GWNNystagmograph2Product Code
- GWQFull-Montage Standard Electroencephalograph2Product Code
- GWRGenerator, Electroencephalograph Test Signal1Product Code
- GWSAnalyzer, Spectrum, Electroencephalogram Signal1Product Code
- GWWAtaxiagraph1Product Code
- GWXFork, Tuning1Product Code
- GWYPinwheel1Product Code
- GWZPercussor1Product Code
- GXBEsthesiometer1Product Code
- GYBMedia, Electroconductive2Product Code
- GYCElectrode, Cortical2Product Code
- GYDTransducer, Tremor2Product Code
- GYEEncephalogram Telemetry System2Product Code
- GZKElectrode, Nasopharyngeal2Product Code
- GZLElectrode, Depth2Product Code
- GZMAnalyzer, Rigidity2Product Code
- GZNRheoencephalograph3Product Code
- GZODevice, Galvanic Skin Response Measurement2Product Code
- GZPStimulator, Mechanical, Evoked Response2Product Code
- HCJDevice, Skin Potential Measurement2Product Code
- HCSDevice, Temperature Measurement, Direct Contact, Powered2Product Code
- JXEDevice, Nerve Conduction Velocity Measurement2Product Code
- JXFPlethysmograph, Ocular3Product Code
- LLNDevice, Vibration Threshold Measurement1Product Code
- LQWTest, Temperature Discrimination1Product Code
- NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid2Product Code
- NTUEvoked Potential Stimulator, Thermal2Product Code
- OLTNon-Normalizing Quantitative Electroencephalograph Software2Product Code
- OLUNormalizing Quantitative Electroencephalograph Software2Product Code
- OLVStandard Polysomnograph With Electroencephalograph2Product Code
- OLWIndex-Generating Electroencephalograph Software2Product Code
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph2Product Code
- OLYMagnetoencephalograph2Product Code
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2Product Code
- OMAAmplitude-Integrated Electroencephalograph2Product Code
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2Product Code
- OMCReduced- Montage Standard Electroencephalograph2Product Code
- ORTBurst Suppression Detection Software For Electroencephalograph2Product Code
- PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid2Product Code
- PKQComputerized Cognitive Assessment Aid2Product Code
- PNAEvoked Photon Image Capture Device1Product Code
- POMComputerized Cognitive Assessment Aid For Concussion2Product Code
- POPCranial Motion Measurement Device2Product Code
- POSPhysiological Signal Based Seizure Monitoring System2Product Code
- PSPIntracranial Pressure & Temperature Monitoring Kit2Product Code
- PTBAtaxiagraph With Interpretive Software1Product Code
- PTYComputerized Cognitive Assessment Aid, Exempt2Product Code
- PVPNeurological Test Kit1Product Code
- QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid2Product Code
- QPFPediatric Autism Spectrum Disorder Diagnosis Aid2Product Code
- OPTInfrared Hematoma Detector2Product Code
- 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
- 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
Axonpen, Axonmonitor, Axonbox, Tablet
- Page Type
- Cleared 510(K)
- 510(k) Number
- K201308
- 510(k) Type
- Traditional
- Applicant
- ClearMind Biomedical
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/27/2020
- Days to Decision
- 196 days
- Submission Type
- Summary