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
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- K221376Nalu Neurostimulation System2Cleared 510(K)
- K203547Nalu Neurostimulation System2Cleared 510(K)
- K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits2Cleared 510(K)
- K201618Nalu Neurostimulation SCS system2Cleared 510(K)
- K191466SandShark Injectable Anchor (SIA) System2Cleared 510(K)
- K190960Nalu Lead Blank (50cm)2Cleared 510(K)
- K182720Freedom Spinal Cord Stimulator (SCS) System2Cleared 510(K)
- K183047Nalu Neurostimulation System2Cleared 510(K)
- K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit2Cleared 510(K)
- K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base2Cleared 510(K)
- K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit2Cleared 510(K)
- K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit2Cleared 510(K)
- K160600Freedom Spinal Cord Stimulator System2Cleared 510(K)
- K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device2Cleared 510(K)
- K150517Freedom Spinal Cord Stimulator System2Cleared 510(K)
- K141399FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM2Cleared 510(K)
- K140272SWIFT-LOCK ANCHOR2Cleared 510(K)
- K130545MULTI LEAD TRIAL CABLE2Cleared 510(K)
- K123299MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS2Cleared 510(K)
- K113611RAPID PROGRAMMER2Cleared 510(K)
- K113805FIXATE TISSUE BAND2Cleared 510(K)
- K113400FIXATE TISSUE BAND2Cleared 510(K)
- K112214OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS2Cleared 510(K)
- K112849FIXATE TISSUE BAND2Cleared 510(K)
- K111462FIXATE TISSUE BAND2Cleared 510(K)
- K102523MULTI-LEAD TRIALING CABLE MODEL 3555312Cleared 510(K)
- K092371SWIFT-LOCK ANCHOR, MODEL 11922Cleared 510(K)
- K091993RAPID PROGRAMMER, VERSION 3.3.02Cleared 510(K)
- K090907PENTA LEAD KITS, MODELS: 3227-32342Cleared 510(K)
- K081208CINCH ANCHOR, MODEL 11942Cleared 510(K)
- K072462WIDE SPACED QUATTRODE LEADS2Cleared 510(K)
- K070847TRIAL CABLE, 30092Cleared 510(K)
- K063080TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS2Cleared 510(K)
- K062041MODEL 3875 1 X 8 SC TEST STIMULATION LEAD2Cleared 510(K)
- K053250ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT2Cleared 510(K)
- K052374RAPID PROGEAMMER 3.02Cleared 510(K)
- K052418AXXESS BUTTERFLY ANCHOR2Cleared 510(K)
- K051773MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS2Cleared 510(K)
- K050922ANS SCS ACCESSORY KIT2Cleared 510(K)
- K050633TRIAL CABLE RETENTION CLIP2Cleared 510(K)
- K040609RAPID PROGRAMMER2Cleared 510(K)
- K040568POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS2Cleared 510(K)
- K033757MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM2Cleared 510(K)
- K033429LAMITRODE SPINAL CORD STIMULATION LEADS2Cleared 510(K)
- K033016PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 38922Cleared 510(K)
- K032751MODIFICATION TO RENEW LEAD EXTENSION2Cleared 510(K)
- K032034ANS AXXESS PERCUTANEOUS LEAD2Cleared 510(K)
- K032349PLACER2Cleared 510(K)
- K032561RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR2Cleared 510(K)
- K030461A127 LEAD EXTENSION2Cleared 510(K)
- K030674MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD2Cleared 510(K)
- K030118RAPID PROGRAMMAR2Cleared 510(K)
- K022222LAMITRODE S-SERIES (S4 AND S8) LEADS2Cleared 510(K)
- K021518PAINDOC2Cleared 510(K)
- K013120PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-182Cleared 510(K)
- K013063GRIP LOCK ANCHOR, MODEL 4113742Cleared 510(K)
- K010300MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION2Cleared 510(K)
- K010008AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX2Cleared 510(K)
- K011584MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF2Cleared 510(K)
- K000445MEDTRONIC MODEL 7499 EXTENSION2Cleared 510(K)
- K994097MEDAMICUS EPIDURAL INTRODUCER2Cleared 510(K)
- K992946RENEW RECEIVER2Cleared 510(K)
- K991784RENEW LEAD EXTENSION2Cleared 510(K)
- K990469LAMITRODE LEADS2Cleared 510(K)
- K990104MEDTRONIC MODEL 7495 EXTENSION KIT2Cleared 510(K)
- K972906MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)2Cleared 510(K)
- K971756MEDTRONIC MODEL 3998 LEAD2Cleared 510(K)
- K972043MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER2Cleared 510(K)
- K964172MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL2Cleared 510(K)
- K953742BIFURCATED Y-EXTENSION2Cleared 510(K)
- K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)2Cleared 510(K)
- K955291DUALSCREEN2Cleared 510(K)
- K954886MODEL NOS. 7495 AND 501826 EXTENSIONS2Cleared 510(K)
- K941342PAIN DOC2Cleared 510(K)
- K952459MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL2Cleared 510(K)
- K943537MODEL 3470 X-TREL RF RECEIVER2Cleared 510(K)
- K934065MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM2Cleared 510(K)
- K950127ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY2Cleared 510(K)
- K945103TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)2Cleared 510(K)
- K930536NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC2Cleared 510(K)
- K930498NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN2Cleared 510(K)
- K940416NEUROLOGICAL LEADS (PACKAGING MODIFICATION)2Cleared 510(K)
- K936099NEUROLOGICAL LEAD ACCESSORIES2Cleared 510(K)
- K934938TEMPORARY SCREENING LEAD/CATHETER KIT2Cleared 510(K)
- K932202MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT2Cleared 510(K)
- K932948MEDTRONIC MODEL 3625 SCREENER SYSTEM2Cleared 510(K)
- K930242INTRODE INT-82Cleared 510(K)
- K921319NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-302Cleared 510(K)
- K924522MEDTRONIC MODEL 3080 PISCES-QUAD LEAD2Cleared 510(K)
- K923931MEDTRONIC MODEL 3487A PISCES-QUAD LEAD2Cleared 510(K)
- K923567MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD2Cleared 510(K)
- K921558MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS2Cleared 510(K)
- K913993MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS2Cleared 510(K)
- K913934MEDTRONIC MODEL 3586 RESUME LEAD2Cleared 510(K)
- K914433MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS2Cleared 510(K)
- K913442MEDTRONIC 3625 SCREENER SYSTEM2Cleared 510(K)
- K912764MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT2Cleared 510(K)
- K905569ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A2Cleared 510(K)
- K905596NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST2Cleared 510(K)
- K905402ANTIGENZ CHLAMYDIA2Cleared 510(K)
- K903690MEDTRONIC (R) MODEL 3625 SCREENER2Cleared 510(K)
- K910199MEDTRONIC MODEL 3487A PISCES-QUAD LEAD2Cleared 510(K)
- K905407MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME2Cleared 510(K)
- K905255NEUROMED MODEL 1992 LS LAMITRODE LEAD2Cleared 510(K)
- K903814NEUROMED TS8 TEST STIMULATOR2Cleared 510(K)
- K901499NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.2Cleared 510(K)
- K890061MODEL 3586 RESUME LEAD2Cleared 510(K)
- K892884MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION2Cleared 510(K)
- K885033MODEL 3487A PISCES EPIDURAL LEAD2Cleared 510(K)
- K884948MODEL 3587A RESUME EPIDURAL LEAD2Cleared 510(K)
- K883780XTREL, MODEL NUMBER 34252Cleared 510(K)
- K881491MODEL 3487A PISCES EPIDURAL LEAD2Cleared 510(K)
- K873675MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD2Cleared 510(K)
- K862915MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)2Cleared 510(K)
- K855107MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT2Cleared 510(K)
- K860185UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER2Cleared 510(K)
- K8601588-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR2Cleared 510(K)
- K853643MULTISTIM LAMINECTOMY ELECTRODE2Cleared 510(K)
- K852326UNISTIM UNT-12Cleared 510(K)
- K852920QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF2Cleared 510(K)
- K852827CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A2Cleared 510(K)
- K844115MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL2Cleared 510(K)
- K841584MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL2Cleared 510(K)
- K833990SPINAL CORD STIMULATION SYS SE-42Cleared 510(K)
- K833809NEURAL STIMULATOR MONITOR2Cleared 510(K)
- K831746PISCES #3487 EPIDURAL LEAD FOR SPINAL2Cleared 510(K)
- K823530STIMUCORD EXTERNAL NEURAL STIM. 911A2Cleared 510(K)
- K820988MEDTRONIC #1992-2 DUAL RATE TRANSMITTER2Cleared 510(K)
- K812155MEDTRONIC DUAL CHANNEL SPINAL CORD STIM2Cleared 510(K)
- K812154MEDTRONIC #3484 PISCES EPIDURAL LEAD2Cleared 510(K)
- K811655MYELOSTAT DORSAL CORD STIMULATOR2Cleared 510(K)
- K810182PROGRAMMABLE SPINAL CORAL STIM. SYSTEM2Cleared 510(K)
- K810319CORDIS STIMUCORD EXTERNAL NEUTRAL STIM2Cleared 510(K)
- K801384MYELOSTAT DORSAL CORD STIMULATOR, ETC.2Cleared 510(K)
- K800193MEDTRONIC PISCES GENERATION II LEAD KIT2Cleared 510(K)
- K790790PISCES-SELECTOR X2Cleared 510(K)
- K780758NEUROLOGICAL SCREENING STIMULATOR M 36232Cleared 510(K)
- K780001EPIDURAL LEAD - MODEL 34812Cleared 510(K)
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- 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
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K162161
- 510(k) Type
- Traditional
- Applicant
- Stimwave Technologies Incorporated
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/16/2016
- Days to Decision
- 136 days
- Submission Type
- Summary