meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
42
Latest Decision
2000-11-24

Clearances · page 39 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K001564 SCAN LT40 (40 CHANNELS) Neuro Scan Labs OLT Class II 2000-11-24
K000651 DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM Cook, Inc. HCG Class II 2000-11-24
K002098 SALUMEDICA NERVE CUFF Salumedica, LLC JXI Class II 2000-11-24
K001692 NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 Neurosoft, Inc. JXE Class II 2000-11-24
K002572 MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 Medtronic PS Medical GWG Class II 2000-11-16
K002476 LUMBOPERITONEAL SHUNT SYSTEM Phoenix Biomedical Corp. JXG Class II 2000-11-09
K000870 KM-10 TENS ELECTRODE Katecho, Inc. GXY Class II 2000-11-07
K002990 VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 Vascular Technology Incorporated HBL Class II 2000-11-06
K002704 KSEA MINIATURE NEUROENDOSCOPE KARL STORZ Endoscopy-America, Inc. GWG Class II 2000-11-03
K001347 MERIDIAN-II AND MERDIAN-PLUS Meridian Co., Ltd. GZO Class II 2000-11-03
K002392 VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V Integra Neurocare, LLC GWM Class II 2000-11-02
K000861 CRANIOCAP Gillette Children'S Specialty Healthcare MVA Class II 2000-10-30
K002316 PHOENIX DIGITAL EEG Axon Systems, Inc. GWQ Class II 2000-10-26
K001096 BURR HOLE COVER, MODEL XX Image-Guided Neurologics, Inc. GXR Class II 2000-10-25
K002903 ANSPACH ANGLED MICRONOSE ATTACHMENT The Anspach Effort, Inc. HBE Class II 2000-10-24
K002622 BIOSLEEP Oxford Biosignals Limited OLZ Class II 2000-10-23
K002631 ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG Eemagine Medical Imaging Solutions GmbH OLX Class II 2000-10-23
K002788 KSEA NEURO-FIBERSCOPE KARL STORZ Endoscopy-America, Inc. GWG Class II 2000-10-23
K002773 NEUROMAP WITH NEURO 100 Radionics, Inc. GWF Class II 2000-10-23
K002389 BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY Baylis Medical Co., Inc. GXI Class II 2000-10-23
K000963 DA VINCHI EEG AND EMG/EP SYSTEMS Airsep Corp. GWF Class II 2000-10-20
K002330 NAVIGUS PEEL AWAY INTRODUCER Image-Guided Neurologics, Inc. GWG Class II 2000-10-18
K002871 MODIFICATION TO YASARGIL ANEURYSM CLIPS Aesculap, Inc. HCH Class II 2000-10-13
K002332 EEG SPIKE AND EVENT DETECTOR MODULE Excel Tech. , Ltd. OMB Class II 2000-10-06
K002523 ADVANTAGE DRIVE SYSTEM Linvatec Corp. HBC Class II 2000-10-06
K002732 STRYKER NAVIGATION SYSTEM - ENT MODULE Stryker Corp. HAW Class II 2000-10-02
K001980 ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 Aspect Medical Systems, Inc. GXY Class II 2000-09-27
K992465 SOPHY SU8 PRESSURE ADJUSTABLE VALVE Sophysa SA JXG Class II 2000-09-21
K002837 BIS ENGINE Aspect Medical Systems, Inc. OLW Class II 2000-09-19
K002734 ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 Aspect Medical Systems, Inc. GXY Class II 2000-09-14
K002570 BIO-LOGIC CEEGRAPH NETLINK Bio-Logic Systems Corp. GWQ Class II 2000-09-14
K001642 INSIGHT IMAGE GUIDED SURGICAL SYSTEM Surgical Insights, Inc. HAW Class II 2000-09-12
K991502 MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 Medtronic PS Medical JXG Class II 2000-09-12
K000919 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 Excel Tech. , Ltd. GWQ Class II 2000-08-31
K994022 PARALLAX CRANIOSET Parallax Medical, Inc. GXP Class II 2000-08-31
K002276 PSI SKULL CLAMP V. Mueller Neuro/Spine HBL Class II 2000-08-29
K001588 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 Arthrocare Corp. GXI Class II 2000-08-17
K002181 GDC ULTRASOFT COIL Boston Scientific, Target HCG Class II 2000-08-11
K002063 BIOTRACE, MODEL 1730 Bryan Corp. MYU Class II 2000-08-10
K001808 DORO HEADREST SYSTEM Pro-Med Instruments GmbH HBL Class II 2000-08-04
K991522 MICROTARGETING ELECTRODE FHC, Inc. GZL Class II 2000-08-04
K992226 XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM Radionics, Inc. JXG Class II 2000-08-04
K002053 NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 Orthosoft, Inc. HAW Class II 2000-08-03
K990100 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE Te ME NA S.A.R.L. GXZ Class II 2000-08-02
K001467 DA VINCHI EMG/EP ISA1004EP Airsep Corp. GWE Class II 2000-08-01
K001950 OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. HAW Class II 2000-07-26
K001630 KSEA BIPOLAR COAGULATING ELECTRODES Karl Storz Endoscopy GWG Class II 2000-07-19
K001324 SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) Neuro Scan Labs OLT Class II 2000-07-11
K001167 OPI BAND Orthomerica Products, Inc. MVA Class II 2000-07-07
K994266 FDTENS 2010 Fuji Dynamics Limited GZJ Class II 2000-07-06
K994265 MEDISANA DIGITAL TENS Fuji Dynamics Limited GZJ Class II 2000-07-06
K001117 COMFORT STIM R & D Medical Products, Inc. GXY Class II 2000-07-05
K001110 CRYSTAL-EEG MODEL 15 Cleveland Medical Devices, Inc. OMC Class II 2000-07-05
K001069 MODEL 4000 EEG MONITOR WITH PSI (PSA4000) Physiometrix, Inc. OLW Class II 2000-06-30
K001801 STEATHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation HAW Class II 2000-06-30
K001101 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 Excel Tech. , Ltd. GWF Class II 2000-06-30
K001103 WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) Excel Tech. , Ltd. GWQ Class II 2000-06-30
K001705 STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF Chester Labs, Inc. GYB Class II 2000-06-29
K000565 MODIFICATION TO NC-STAT Neurometrix, Inc. JXE Class II 2000-06-27
K000947 ULTRASTIM ELECTRODE, MODEL US4040 Axelgaard Mfg. Co., Ltd. GXY Class II 2000-06-16
K000892 DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES Datex-Ohmeda, Inc. OLT Class II 2000-06-16
K001284 STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM Medtronic Surgical Navigation Technologies HAW Class II 2000-06-12
K984376 ENDOR 2000 T.C. Medical, Inc. GZJ Class II 2000-06-07
K001192 SELF ADHERING NAVIGUS GUIDE Image-Guided Neurologics, Inc. HAW Class II 2000-06-07
K000405 INTERCURE LTD. RESPI-LOW Intercure , Ltd. HCC Class II 2000-05-17
K001431 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. HAW Class II 2000-05-17
K001013 MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY Airsep Corp. OLV Class II 2000-05-16
K001055 MODEL 4300 PSARRAY EEG ELECTRODE SET Physiometrix, Inc. GXY Class II 2000-05-11
K000514 RUMBAR DRAINAGE SYSTEM Phoenix Biomedical Corp. JXG Class II 2000-05-10
K001153 MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation HAW Class II 2000-05-03
K001083 GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 Boston Scientific, Target HCG Class II 2000-05-03
K982101 SHELHIGH NO-REACT DURA SHIELD Shelhigh, Inc. GXQ Class II 2000-05-02
K000445 MEDTRONIC MODEL 7499 EXTENSION Medtronic Vascular GZB Class II 2000-04-28
K991549 EMBOSPHERE MICROSPHERES Biosphere Medical HCG Class II 2000-04-26
K000338 VITAPORT 3 Nihon Kohden America, Inc. OLV Class II 2000-04-26
K000195 CRANIAL DRILL Image-Guided Neurologics, Inc. HBB Class II 2000-04-20
K000865 QUIK-CAP Neuroscan GXY Class II 2000-04-18
K000898 EEG WITH VIDEO, MODEL EX-NW Excel Tech. , Ltd. GWQ Class II 2000-04-14
K000105 MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), Medtronic Vascular GZF Class II 2000-04-12
K992173 SIPHONGUARD CSF CONTROL DEVICE Johnson & Johnson Professionals, Inc. JXG Class II 2000-04-07
K993019 PACIFIC SURGICAL PATTIES V. Mueller Neuro/Spine HBA Class II 2000-03-30
K983214 RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES Rita Medical Systems GXD Class II 2000-03-27
K994344 NEUROTHERM RF CANNULA Rocket Medical Plc GXI Class II 2000-03-21
K000057 RADIONICS LUMBOPERITONEAL SHUNT Radionics, Inc. JXG Class II 2000-03-20
K994387 RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL Woodside Biomedical, Inc. GZJ Class II 2000-03-16
K993568 MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L Machida Endoscope Co., Ltd. GWG Class II 2000-03-13
K000171 CBYON SURGICAL OPERATING SYSTEM (SOS) Cbyon, Inc. HAW Class II 2000-03-13
K991413 CODMAN ETHISORB DURA PATCH Johnson & Johnson Professionals, Inc. GXQ Class II 2000-03-13
K000068 COMPUMEDICS E-SERIES EEG SYSTEM Compumedics Neuro Science Pty , Ltd. OLT Class II 2000-03-13
K994142 GRASS TS3201/6401 EEG AMPLIFIER SYSTEM Grass Instrument Co. OLV Class II 2000-03-06
K994097 MEDAMICUS EPIDURAL INTRODUCER Medamicus, Inc. GZB Class II 2000-03-01
K000073 MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA Mercury Medical GXI Class II 2000-03-01
K994421 SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION Surgical Navigation Specialists, Inc. HAW Class II 2000-02-23
K992461 STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. HAW Class II 2000-02-22
K993990 LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM Stryker Instruments GXN Class II 2000-02-22
K000310 VOYAGER 6.0 SOFTWARE OPTION Philips Medical Systems (Cleveland), Inc. HAW Class II 2000-02-15
K991397 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS Sein Electronics Co., Ltd. GZJ Class II 2000-02-11
K994191 SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T Nmt Medical, Inc. HCI Class II 2000-02-08
K992652 SD-730 IF-SDS, PERFECT PULSE IF-SDS Skylark Device & Systems Co., Ltd. LIH Class II 2000-02-03
K993654 NEUROCOMP Neurocybernetics HCC Class II 2000-01-27

6,130 clearances in the Neurology panel. Data: openFDA.