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
- 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
- K241327Navient Image Guide Navigation System (955-NC-NC), Cranial2Cleared 510(K)
- K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT2Cleared 510(K)
- K243657ClearPoint System (Software Version 3.0)2Cleared 510(K)
- K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)2Cleared 510(K)
- K242480FLASH EVD System (10-0002)2Cleared 510(K)
- K242351Zeta Cranial Navigation System (ZNS131-US)2Cleared 510(K)
- K233703Bone Anchor (NGS-BA-01)2Cleared 510(K)
- K233144ClearPoint Bone Screw Fiducials2Cleared 510(K)
- K233155ClearPointer Optical Navigation Wand2Cleared 510(K)
- K233141SmartFrame OR2Cleared 510(K)
- K233903Zeta Cranial Navigation System (ZNS131-US)2Cleared 510(K)
- K233243ClearPoint System (Software Version 2.2)2Cleared 510(K)
- K231976StealthStation Cranial Software, v3.1.5 (9735585)2Cleared 510(K)
- K232102ClearPoint Array System (Version 1.2)2Cleared 510(K)
- K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial2Cleared 510(K)
- K230661Zeta Cranial Navigation System2Cleared 510(K)
- K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI2Cleared 510(K)
- K231103ROSA ONE Brain Application2Cleared 510(K)
- K231392NaviNetics Reusable Stereotactic System (NN1000)2Cleared 510(K)
- K220072Sinobot X12Cleared 510(K)
- K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial2Cleared 510(K)
- K223577Localite TMS Navigator TS2Cleared 510(K)
- K221544MagVenture TMS Atlas Neuro Navigation System2Cleared 510(K)
- K230201Disposable Pre-calibrated Brain Biopsy Needle 2.02Cleared 510(K)
- K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System2Cleared 510(K)
- K222519ClearPoint System2Cleared 510(K)
- K213989Cranial EM System2Cleared 510(K)
- K220897Disposable Brain Biopsy Needle 2.02Cleared 510(K)
- K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.42Cleared 510(K)
- K214065ROSA ONE Brain application2Cleared 510(K)
- K214040ClearPoint Array System (version 1.1)2Cleared 510(K)
- K210109visor2 system2Cleared 510(K)
- K212397StealthStation S8 Cranial v2.02Cleared 510(K)
- K201435Molecular Flow Simulations2Cleared 510(K)
- K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System2Cleared 510(K)
- K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization2Cleared 510(K)
- K203251SOLOPASS System2Cleared 510(K)
- K210700NaviNetics D1 Stereotactic System2Cleared 510(K)
- K201752Disposable Pre-calibrated Suction2Cleared 510(K)
- K202575ClearPoint Array System2Cleared 510(K)
- K203639StealthStation Cranial Software v1.3.22Cleared 510(K)
- K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update2Cleared 510(K)
- K201175StealthStation Cranial Software v1.3.02Cleared 510(K)
- K200511ROSA ONE Brain application2Cleared 510(K)
- K191422Neural Navigator2Cleared 510(K)
- K200079ClearPoint System and Accessories2Cleared 510(K)
- K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application2Cleared 510(K)
- K191597Stealth Autoguide System, Midas Rex Legend Depth Stop System2Cleared 510(K)
- K190250Microscope Navigation2Cleared 510(K)
- K1832767D Surgical System2Cleared 510(K)
- K190887Leksell Vantage Stereotactic System2Cleared 510(K)
- K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.12Cleared 510(K)
- K183325Modus Nav2Cleared 510(K)
- K191400Voyager Trajectory Array Guide (V-TAG)2Cleared 510(K)
- K182417ROSA ONE Brain Application2Cleared 510(K)
- K182000AQrate Robotic Assistance System2Cleared 510(K)
- K1810417D Surgical System Cranial Application2Cleared 510(K)
- K181706neuromate Gen III2Cleared 510(K)
- K180854Voyager Trajectory Array Guide (V-TAG)2Cleared 510(K)
- K180206neuromate Gen III2Cleared 510(K)
- K172444ROSA BRAIN (v3.0.0.5)2Cleared 510(K)
- K172820Microscope Navigation Software2Cleared 510(K)
- K171123Leksell Vantage Stereotactic System2Cleared 510(K)
- K163666neuro inspire2Cleared 510(K)
- K163209Fiagon Navigation System2Cleared 510(K)
- K163439NaviENT2Cleared 510(K)
- K162655StealthConnect Remote Viewing, Planning and Collaboration System2Cleared 510(K)
- K162309StealthStation S8 System Platforms and StealthStation Cranial Software2Cleared 510(K)
- K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker2Cleared 510(K)
- K162604Cranial Reducing Tubes2Cleared 510(K)
- K160811CRW STEREOTACTIC SYSTEM2Cleared 510(K)
- K153660StealthStation System with Cranial Software2Cleared 510(K)
- K152764EXACTECH GPS2Cleared 510(K)
- K160523BrightMatter Guide with BrightMatter Pointer2Cleared 510(K)
- K151156Fiagon Navigation System2Cleared 510(K)
- K153281BrightMatter Guide with Surface Trace Registration2Cleared 510(K)
- K160434ClearPoint System2Cleared 510(K)
- K152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit2Cleared 510(K)
- K151359ROSA Brain2Cleared 510(K)
- K143420SYMBIS Surgical System2Cleared 510(K)
- K142505ClearPoint System2Cleared 510(K)
- K150301NavSuite3 Kit2Cleared 510(K)
- K150216Synergy Cranial2Cleared 510(K)
- K143241MDT Navigable Brain Biopsy Cannula2Cleared 510(K)
- K142024BRIGHTMATTER NAVIGATION SYSTEM2Cleared 510(K)
- K141833STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION2Cleared 510(K)
- K142344DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System2Cleared 510(K)
- K141559V-GUIDE FOR VENTRICULOSTOMIES2Cleared 510(K)
- K140705NAVIGABLE BRAIN BIOPSY CANNULA SET2Cleared 510(K)
- K133444STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM2Cleared 510(K)
- K140868STRYKER KWIC NEEDLE2Cleared 510(K)
- K132755NEUROMATE FRAMELESS GEN II2Cleared 510(K)
- K132611MICROTABLE SYSTEM2Cleared 510(K)
- K131214CRANIAL MAP NEURO2Cleared 510(K)
- K130874STRYKER NAV3I PLATFORM2Cleared 510(K)
- K130608QUADCUT2Cleared 510(K)
- K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS2Cleared 510(K)
- K122096KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM2Cleared 510(K)
- K121950MICROTARGETING XL STAR DRIVE SYSTEM2Cleared 510(K)
- K120812RENAISSANCE2Cleared 510(K)
- K110644PRAEZIS PLUS2Cleared 510(K)
- K112094BRAIN BIOPSY NEEDLE2Cleared 510(K)
- K111558SURGICASE GUIDE2Cleared 510(K)
- K112469GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM2Cleared 510(K)
- K113228RENAISSANCE SYSTEM2Cleared 510(K)
- K101627IPLAN2Cleared 510(K)
- K110911RENAISSANCE SYSTEM2Cleared 510(K)
- K103192NAVIGATION MARKER, REFLECTIVE MARKER SPHERES2Cleared 510(K)
- K101791ROSA SURGICAL DEVICE2Cleared 510(K)
- K102130TENZING SYSTEM2Cleared 510(K)
- K100038DISPOSABLE REFLECTIVE MARKER SPHERES2Cleared 510(K)
- K092467VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED2Cleared 510(K)
- K100314IMNS MEDACTA NAVIGATION SYSTEM,33.221000US2Cleared 510(K)
- K092192WAYPOINT STEREOTACTIC SYSTEM2Cleared 510(K)
- K092239ROSA SURGICAL DEVICE, MODEL ROSA 1.12Cleared 510(K)
- K090190WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K083597SONOWAND INVITE2Cleared 510(K)
- K092562MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS2Cleared 510(K)
- K090240MONTERIS MEDICAL UFO2Cleared 510(K)
- K082060CRANIAL IMAGE GUIDED SURGERY SYSTEM2Cleared 510(K)
- K080355LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS2Cleared 510(K)
- K083565PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.02Cleared 510(K)
- K081867MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.02Cleared 510(K)
- K082267PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.12Cleared 510(K)
- K073615BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED2Cleared 510(K)
- K081232TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES2Cleared 510(K)
- K080875PIGALILEO 4TH GENERATION SYSTEM2Cleared 510(K)
- K080450STRYKER POWER TOOL NAVIGATOR ATTACHMENT2Cleared 510(K)
- K080678UNI-KNEE 2.02Cleared 510(K)
- K080547ORTHOPILOT NEXT GENERATION, MODEL FS101-FS1062Cleared 510(K)
- K073467SPINEASSIST SYSTEM2Cleared 510(K)
- K080250LEKSELL SURGIPLAN, MODEL 10069472Cleared 510(K)
- K072899ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.02Cleared 510(K)
- K072806MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)2Cleared 510(K)
- K072271STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE2Cleared 510(K)
- K072267TOTAL HIP SURGETICS NAVIGATION SYSTEM2Cleared 510(K)
- K072716VECTOR VISION HIP2Cleared 510(K)
- K072573VECTORVISION HIP AND HIP SR2Cleared 510(K)
- K070556BRAINSUITE NET2Cleared 510(K)
- K071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL2Cleared 510(K)
- K063607SPINEASSIST SYSTEM2Cleared 510(K)
- K070731PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM2Cleared 510(K)
- K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-060032Cleared 510(K)
- K071334DEPUY CAS HEMI ASR HIP INSTRUMENTS2Cleared 510(K)
- K071135DEPUY CI HIP INSTRUMENTATION2Cleared 510(K)
- K070106VV FLUORO 3D2Cleared 510(K)
- K061479ARGOS2Cleared 510(K)
- K063408CTLOGICS NAVIGATIONS SYSTEMS2Cleared 510(K)
- K062358MODIFICATION TO VECTORVISION TRAUMA2Cleared 510(K)
- K062640STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-0002Cleared 510(K)
- K063028VECTORVISION HIP SR2Cleared 510(K)
- K062228ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION2Cleared 510(K)
- K061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM2Cleared 510(K)
- K062086NAVIVISION2Cleared 510(K)
- K061224LAPDOC I2Cleared 510(K)
- K061248AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K062146UNI KNEE SURGETICS NAVIGATION SYSTEM2Cleared 510(K)
- K060727VECTORVISION HIP2Cleared 510(K)
- K053348STRYKER ORTHOPAEDICS RFID INSTRUMENTATION2Cleared 510(K)
- K060556BRIGIT SURGICAL DEVICE2Cleared 510(K)
- K060808BRAINPRO, BRAINPRO ACCESS2Cleared 510(K)
- K053159VECTORVISION SPINE2Cleared 510(K)
- K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-050022Cleared 510(K)
- K060282TOTAL KNEE SURGETICS NAVIGATION SYSTEM2Cleared 510(K)
- K053542SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM2Cleared 510(K)
- K053164IPLAN FLOW2Cleared 510(K)
- K060121BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS2Cleared 510(K)
- K060468VECTORVISION HIP2Cleared 510(K)
- K052623IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K052966CI KNEE, CI MI TKR2Cleared 510(K)
- K053127IPLAN2Cleared 510(K)
- K052425ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION2Cleared 510(K)
- K052840IGI-SYSTEM2Cleared 510(K)
- K051734GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 10069552Cleared 510(K)
- K052851VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)2Cleared 510(K)
- K052213NAVIGATION SW HIP 3.1 ON CI2Cleared 510(K)
- K052178DEPUY CAS HIP INSTRUMENTATION2Cleared 510(K)
- K051676SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES2Cleared 510(K)
- K050651MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION2Cleared 510(K)
- K051746ELEKTA ESARTE FRAME SYSTEM2Cleared 510(K)
- K051724ACUMEN IMAGE GUIDED SURGICAL SYSTEM2Cleared 510(K)
- K051029STELTHSTATION WIRELESS SURGEON MOUSE2Cleared 510(K)
- K031196SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM2Cleared 510(K)
- K050438STEALTHSTATION SYSTEM UPDATE2Cleared 510(K)
- K041897MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-012Cleared 510(K)
- K050897NAVIPRO SHOULDER SOFTWARE MODULE2Cleared 510(K)
- K050973MODIFICATION TO: VOYAGER LINUX2Cleared 510(K)
- K042543IPLAN! DIGITAL TEMPLATING2Cleared 510(K)
- K050752AESCULAP ORTHOPILOT 2 THA V 2.02Cleared 510(K)
- K050772NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-20002Cleared 510(K)
- K050615STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-0002Cleared 510(K)
- K042721KOLIBRI SPINE2Cleared 510(K)
- K050377NBD HEAD SCREW2Cleared 510(K)
- K043223DEPUY CAS KNEE INSTRUMENTATION2Cleared 510(K)
- K042513VECTORVISION OSTEOTOMY2Cleared 510(K)
- K043091NAVIGUS NEXDRIVE, MODEL MI-30002Cleared 510(K)
- K043536NAVITRACK SYSTEM - S&N IMAGE FREE KNEE2Cleared 510(K)
- K042512VECTORVISION ACL2Cleared 510(K)
- K043088MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE2Cleared 510(K)
- K041477PATHFINDER2Cleared 510(K)
- K041703IPLAN!2Cleared 510(K)
- K042391KOLIBRI IMAGE GUIDED SURGERY SYSTEM2Cleared 510(K)
- K041899VECTORVISION UNI-KNEE2Cleared 510(K)
- K040334NAVIGUS PASSIVE PROBE, MODEL NP-10002Cleared 510(K)
- K041330IPLAN! FLOW2Cleared 510(K)
- K033341SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS2Cleared 510(K)
- K040368VECTORVISION HIP 3.02Cleared 510(K)
- K040979ELEKTA MICRODRIVE, MODEL 9167162Cleared 510(K)
- K031454ACUMEN SURGICAL NAVIGATION SYSTEM2Cleared 510(K)
- K041369NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-030172Cleared 510(K)
- K040834NAVIGUS PASSIVE PROBE (BL), MODEL NP-20002Cleared 510(K)
- K033668NAVIPRO KNEE SOFTWARE MODULE2Cleared 510(K)
- K033619NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-40002Cleared 510(K)
- K033223ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS2Cleared 510(K)
- K023651VECTORVISION CRANIAL/ENT2Cleared 510(K)
- K033340LEKSELL SURGIPLAN WITH IMAGEMERGE2Cleared 510(K)
- K033011ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS2Cleared 510(K)
- K033621NDI PASSIVE SPHERES2Cleared 510(K)
- K033413SPINEASSIST DEVICE2Cleared 510(K)
- K032917NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE2Cleared 510(K)
- K031732EBI ACUMEN SURGICAL NAVIGATION SYSTEM2Cleared 510(K)
- K032054RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE2Cleared 510(K)
- K031337ACUMEN SURGICAL NAVIGATION SYSTEM2Cleared 510(K)
- K031770CI TKR/UKR2Cleared 510(K)
- K031999ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT2Cleared 510(K)
- K031980MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM2Cleared 510(K)
- K024192VECTORVISION FLUORO3D2Cleared 510(K)
- K022579STRYKER NAVIGATION SYSTEM-KNEE MODULE2Cleared 510(K)
- K030827NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.2042Cleared 510(K)
- K031156NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.0052Cleared 510(K)
- K023424IGI-SYSTEM2Cleared 510(K)
- K030343DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE2Cleared 510(K)
- K030764Z-BOX2Cleared 510(K)
- K030552IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K024201NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-20002Cleared 510(K)
- K023949NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES2Cleared 510(K)
- K030106STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE2Cleared 510(K)
- K022364NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.2002Cleared 510(K)
- K022365STRYKER NAVIGATION SYSTEM - HIP MODULE2Cleared 510(K)
- K022126CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K023975VOYAGER LINUX2Cleared 510(K)
- K021798SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS2Cleared 510(K)
- K021980HIP MODULE FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K021306VECTORVISION CT-FREE KNEE2Cleared 510(K)
- K021815SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS2Cleared 510(K)
- K022100NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-10102Cleared 510(K)
- K020631IPLAN2Cleared 510(K)
- K021760NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.1202Cleared 510(K)
- K022460SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS2Cleared 510(K)
- K022414STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE2Cleared 510(K)
- K022074SPHERZ2Cleared 510(K)
- K013396ALPHA DRIVE SYSTEM2Cleared 510(K)
- K021327ORTHOPILOT HTO MODULE2Cleared 510(K)
- K014256KOLIBRI IGS SYSTEMS2Cleared 510(K)
- K014113ENDOMAP2Cleared 510(K)
- K020764NAVIPRO2Cleared 510(K)
- K020298GALILEO CAS/NAV TKR SYSTEM2Cleared 510(K)
- K013569ORTHOPILOT 22Cleared 510(K)
- K013428MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM2Cleared 510(K)
- K012448VECTORVISION TRAUMA2Cleared 510(K)
- K020338STEALTHSTATION WITH FLUOROMERGE SOFTWARE2Cleared 510(K)
- K012938SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS2Cleared 510(K)
- K012937KNEE MODULE FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K0112553D LINE STEROTACTIC HARDWARE ACCESSORIES2Cleared 510(K)
- K013861MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE2Cleared 510(K)
- K012380MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY2Cleared 510(K)
- K013257HEMI-ARC SURGICAL NAVIGATOR2Cleared 510(K)
- K012719NAVIGUS II MR2Cleared 510(K)
- K012886CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE2Cleared 510(K)
- K013025MODIFICATION TO FLOUROLAB PLUS2Cleared 510(K)
- K012366NAVIGUS II TRAJECTORY GUIDE2Cleared 510(K)
- K010602VECTORVISION HIP2Cleared 510(K)
- K012564MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM2Cleared 510(K)
- K010612VECTORVISION KNEE2Cleared 510(K)
- K010204STRYKER NAVIGATION SYSTEM-KNEE MODULE2Cleared 510(K)
- K011775MICRO TARGETING DRIVE SYSTEM2Cleared 510(K)
- K010968VECTORVISION CT/FLUORO2Cleared 510(K)
- K011992FHC MICROTARGETING DRIVE SYSTEM2Cleared 510(K)
- K011971NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 80002Cleared 510(K)
- K003589VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT2Cleared 510(K)
- K003486STEREOTACTIC FRAME BASED SYSTEM2Cleared 510(K)
- K010542SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION2Cleared 510(K)
- K010427LORENZ FIDUCAIL SCREW2Cleared 510(K)
- K010548MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)2Cleared 510(K)
- K003699MEDIVISION IGS SYSTEM2Cleared 510(K)
- K003776MICROTARGETING DRIVE SYSTEM2Cleared 510(K)
- K003347ORTHOPILOT2Cleared 510(K)
- K003268Z-TOUCH2Cleared 510(K)
- K004027STRYKER REMOTE SURGICAL PLANNING SYSTEM2Cleared 510(K)
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- K003201STEALTHSTATION TREATMENT GUIDANCE PLATFORM2Cleared 510(K)
- K002893FLUOROLAB PLUS2Cleared 510(K)
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- K001801STEATHSTATION TREATMENT GUIDANCE PLATFORM2Cleared 510(K)
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- K001192SELF ADHERING NAVIGUS GUIDE2Cleared 510(K)
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- K994421SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION2Cleared 510(K)
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- K000310VOYAGER 6.0 SOFTWARE OPTION2Cleared 510(K)
- K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX2Cleared 510(K)
- K992916BRAINLAB STEREOTACTIC ARC2Cleared 510(K)
- K992927STEALTHSTATION TREATMENT GUIDANCE PLATFORM2Cleared 510(K)
- K993673SNN FLUORO NAVIGATION SYSTEM2Cleared 510(K)
- K991706VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE2Cleared 510(K)
- K9935013D1 MICROPOSITIONING HEADSTAGE2Cleared 510(K)
- K990683AXON MP-1 MICROPOSITIONER2Cleared 510(K)
- K992843THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F2Cleared 510(K)
- K991256VIEWPOINT ENT/ORTHOPEDIC OPTION2Cleared 510(K)
- K992882LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT2Cleared 510(K)
- K983410@ TARGET2Cleared 510(K)
- K992721COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE2Cleared 510(K)
- K992457SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION2Cleared 510(K)
- K992304NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX2Cleared 510(K)
- K990907REMOTE INTRODUCER, MODEL PI-10002Cleared 510(K)
- K991636ELEKTA STEREOTACTIC GUIDE2Cleared 510(K)
- K991267SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A2Cleared 510(K)
- K983764VIEWPOINT TOOLS- STERRAD2Cleared 510(K)
- K991081FRAMELESS NEUROMATE2Cleared 510(K)
- K984298Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI2Cleared 510(K)
- K983831VECTORVISION22Cleared 510(K)
- K990632OPTICAL TRACKING SYSTEM (OTS)2Cleared 510(K)
- K990214FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM2Cleared 510(K)
- K990860VIEWPOINT MICROSCOPE OPTION2Cleared 510(K)
- K990868VIEWPOINT PASSIVE TOOL OPTION2Cleared 510(K)
- K990326OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII2Cleared 510(K)
- K983539TRAJECTORY GUIDE, MODEL # TGX-XXX2Cleared 510(K)
- K981480PHILIPS EASYGUIDE2Cleared 510(K)
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- K982570SNN SCOUT2Cleared 510(K)
- K984245NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS2Cleared 510(K)
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- K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME2Cleared 510(K)
- K981508VECTORVISION SPINE MODULE2Cleared 510(K)
- K980820PHILIPS EASYGUIDE2Cleared 510(K)
- K982244MAYFIELD ACCISS OPTICAL SYSTEM2Cleared 510(K)
- K961903MAGELLAN2Cleared 510(K)
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- K972324LEKSELL STEREOTACTIC SYSTEM2Cleared 510(K)
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- K974161STEALTHSTATION SYSTEM2Cleared 510(K)
- K973277CAROLINE GUIDE/DELIA LOCALIZER2Cleared 510(K)
- K972398STEALTHSTATION PASSIVE INSTRUMENT OPTION2Cleared 510(K)
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- K971247SNT DISPOSABLE BIOPSY NEEDLE2Cleared 510(K)
- K970865ISG FAMILY OF VIEWING WANDS2Cleared 510(K)
- K964801OPTICAL TRACKING SYSTEM (OTS)2Cleared 510(K)
- K962939VECTORVISION2Cleared 510(K)
- K970604VIEWPOINT - 3.0 SOFTWARE2Cleared 510(K)
- K963256NEUROMATE STEREOTACTIC SYSTEM2Cleared 510(K)
- K965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM2Cleared 510(K)
- K963221OPTICAL DIGITIZER OPTION FOR VIEW POINT2Cleared 510(K)
- K961834PHILIPS EASYGUIDE NEURO2Cleared 510(K)
- K963173STEALTHSTATION SYSTEM2Cleared 510(K)
- K961844OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]2Cleared 510(K)
- K954789BRAINLAB HEADPINS2Cleared 510(K)
- K961858COSGROVE DEPTH ELECTRODE KIT(CDEK)2Cleared 510(K)
- K961639LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)2Cleared 510(K)
- K960714ISG VIEWING WAND2Cleared 510(K)
- K961120MARKER SYSTEM FOR STEREOTAXIC NAVIGATION2Cleared 510(K)
- K955397MAYFIELD-ACCISS WORKSTATION2Cleared 510(K)
- K953568CODMAN FIDUCIAL MARKER SYSTEM2Cleared 510(K)
- K952390BRAINLAB STEROTATIC HEADRING2Cleared 510(K)
- K954276STEALTHSTATION2Cleared 510(K)
- K944463CRW-1 SYSTEM2Cleared 510(K)
- K935456REGULUS MEASUREMENT UNIT2Cleared 510(K)
- K946033LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE2Cleared 510(K)
- K946252STEREOPLAN2Cleared 510(K)
- K943468LEKSELL SURGIPLAN2Cleared 510(K)
- K936019NOMOS STEREOTACTIC BIOPSY INSTRUMENTS2Cleared 510(K)
- K931991GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION2Cleared 510(K)
- K924348AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC2Cleared 510(K)
- K915791CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION2Cleared 510(K)
- K915819BRAINSCAN WORKSTATION2Cleared 510(K)
- K901883STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE2Cleared 510(K)
- K901670GNOMOS STEREOTACTIC DEVICE2Cleared 510(K)
- K900200COOK STEREOTAXIC GUIDE2Cleared 510(K)
- K894387WESTCO MADAYAG PAB NEEDLE2Cleared 510(K)
- K894263CASS SYSTEM2Cleared 510(K)
- K881132LAITINEN'S TRIGEMINUS STEREOGUIDE2Cleared 510(K)
- K881131THE LAITINEN STEREOTACTIC SYSTEM2Cleared 510(K)
- K874693OBT STEREOTACTIC SYSTEM2Cleared 510(K)
- K874833ARC ADAPTER ASSEMBLY2Cleared 510(K)
- K872877TARGET PROGRAM & EPSON HX-20 COMPUTER2Cleared 510(K)
- K871046COMPASS STEREOTACTIC POSITIONING SYSTEM2Cleared 510(K)
- K861629KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES2Cleared 510(K)
- K862220COMPASS CT STEREOTACTIC ADAPTATION SYSTEM2Cleared 510(K)
- K854475GHAJAR INTRAVENTRICULAR CATHETER GUIDE2Cleared 510(K)
- K852662GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY2Cleared 510(K)
- K852477KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS2Cleared 510(K)
- K851973DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY2Cleared 510(K)
- K851659SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE2Cleared 510(K)
- K833484COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC2Cleared 510(K)
- K830999DAP II BIOPSY GUIDE2Cleared 510(K)
- K831329PMT VAXIOM STEREOTACTIC SYS #FX0012Cleared 510(K)
- K823424MENISCECTOMY TRAY #97152Cleared 510(K)
- K823675FRONING GUIDANCE SYSTEM #TX-82002Cleared 510(K)
- K812744LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER2Cleared 510(K)
- K811452BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM2Cleared 510(K)
- K790502DYONICS STEROTOXIC POSITIONER2Cleared 510(K)
- 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
- 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
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K152558
- 510(k) Type
- Special
- Applicant
- ELEKTA INSTRUMENT AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/2/2016
- Days to Decision
- 175 days
- Submission Type
- Statement