Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- LEMHuman Lyophilized Dura Mater2Product Code
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief3Product Code
- LHYElectrode, Stabilized Epidural Spinal3Product Code
- LIIMonitor, Intracranial Pressure, Implanted3Product Code
- LKWLaser, Neurosurgical3Product Code
- LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease3Product Code
- LLFLaser, Neurosurgical, Argon3Product Code
- LLPLaser For Pain Therapy3Product Code
- LMEMonitor, Blood-Flow, Cerebral, Thermal Diffusion3Product Code
- LQDRecorder, Attention Task PerformanceUProduct Code
- LYIStimulator, Subcortical, Implanted For Epilepsy3Product Code
- LYJStimulator, Autonomic Nerve, Implanted For Epilepsy3Product Code
- MBXStimulator, Thalamic, Epilepsy, Implanted3Product Code
- BWKStimulator, Electro-AcupunctureUProduct Code
- KGFAdhesive, Tissue For Aneurysmorrhaphy3Product Code
- KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations3Product Code
- LBKDevice, Neurosurgical Fragmentation And AspirationUProduct Code
- MFEAgent, Injectable, Embolic3Product Code
- MFRStimulator, Brain, Implanted, For Behavior ModificationFProduct Code
- MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor3Product Code
- MHZStimulator, Vestibular Acceleration, Therapeutic3Product Code
- MKDStimulator, Functional Walking Neuromuscular, Non-Invasive3Product Code
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)3Product Code
- MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)FProduct Code
- MUZStimulator, Autonomic Nerve, Implanted (Depression)3Product Code
- MVVDevice, AcupressureUProduct Code
- MXMCap, Cooling (Infants)3Product Code
- NHLStimulator, Electrical, Implanted, For Parkinsonian Symptoms3Product Code
- NJEIntracranial Neurovascular StentFProduct Code
- NPEMaterial, Embolization, Neurovascular, Polymerizing Or Precipitating3Product Code
- NQRSealant, Dural3Product Code
- NZKStimulator, Low Electric Field, Tumor Treatment3Product Code
- OBAPolymerizing, Neurovascular Embolization MaterialFProduct Code
- OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)FProduct Code
- OPRIntrasaccular Flow Disruption Device3Product Code
- OUTIntracranial Aneurysm Flow Diverter3Product Code
- OUUPolymeric Neurovascular EmbolizationFProduct Code
- OVCHeadframeNProduct Code
- OZJInhibitor, Postoperative Fibrosis (Adhesion Barrier)NProduct Code
- PAXSurgical KitFProduct Code
- PCQInhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)NProduct Code
- PFNImplanted Brain Stimulator For Epilepsy3Product Code
- PJSStimulator, Electrical, Implanted, For Essential Tremor3Product Code
- PMPDorsal Root Ganglion Stimulator For Pain Relief3Product Code
- POHMr-Guided Focused Ultrasound System3Product Code
- QCAIntracranial Coil-Assist Stent3Product Code
- QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief3Product Code
- QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy3Product Code
- QSLBrain Temperature Measurement System2Product Code
- QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms2Product Code
- QWDStimulator, Nerve, For Restless Legs Syndrome2Product Code
- QTKTemporary Percutaneous Transluminal Cerebral Artery Dilatation DeviceFProduct Code
- SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb3Product Code
- QWTPrognostic Assessment Software Of Mild Cognitive Impairment2Product Code
- SBGIn Situ Polymerizing Peripheral Nerve Cap2Product Code
- SDGBrain Intraparenchymal Infusion Cannula2Product Code
- SDXNeuromuscular Stimulator And Exercise Evaluation System2Product Code
- SEEComputerized Behavioral Therapy Device For Migraine2Product Code
- SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring2Product Code
- SFDIn Situ Polymerizing Peripheral Nerve Repair Device2Product Code
- SFNNon-Invasive Evoked Response Brain Stimulator2Product Code
- SFJVagus Nerve Stimulator For Rheumatoid Arthritis3Product Code
- SGBPain Assessment Software In Non-Communicative Adults2Product Code
- SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation2Product Code
- SGSDeep Brain Stimulation For The Treatment Of Dystonia3Product Code
- SGUNeurovascular Liquid Embolic Agent3Product Code
- SGFDural Arteriovenous Fistula Liquid EmbolicFProduct Code
- Submissions with No Product CodeMiscellaneous
- K251958VEINOPLUS BackCleared 510(K)
- K092117SCENAR, MODEL 10Cleared 510(K)
- P970049DISHLER EXCIMER LASER SYSTEMSAPWDPMA Approval
- P960033STAARVISC TM SODIUM HYALURONATEAPWDPMA Approval
- P960034CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.APWDPMA Approval
- K864679DZIDRA GLASS FOR USE IN GENERAL MEDICALCleared 510(K)
- K864678DZIDRA GLASS FOR USE IN NEUROLOGYCleared 510(K)
- K864656DZIDRA GLASS FOR USE IN OPHTHALMOLOGYCleared 510(K)
- K864655DZIDRA GLASS FOR USE IN DENTISTRYCleared 510(K)
- K864754BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCARCleared 510(K)
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMAPPRPMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA PC NEUROSTIMULATOROK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P030017PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P030017PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMSOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA TM SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P030017PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P960009ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMSOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P030017PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMOK30PMA Approval
- P960034POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSESAPPRPMA Approval
- P970049DISHLER EXCIMER LASER SYSTEMSAPWDPMA Approval
- P960033STAARVISC TM SODIUM HYALURONATEAPWDPMA Approval
- P960034CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.APWDPMA Approval
- K864117SUPPORT ARMCleared 510(K)
- K854533SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2Cleared 510(K)
- K850006TENSCleared 510(K)
- K844592MTA 86Cleared 510(K)
- K842691HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHYCleared 510(K)
- K842625CUSTOM NEURO TRAYCleared 510(K)
- K842879ALPHACOILCleared 510(K)
- K834501ANGIOSCANE SPECTRUM ANALYZERCleared 510(K)
- K833734NEUROLOGICAL SPONGE ON PLASTIC STICKCleared 510(K)
- K840725CLINICAL CARE STIMULATORCleared 510(K)
- K832405OPTHALMIC ENDOSCOPECleared 510(K)
- K832393ENCODYNE 4 & VACUFIX 4Cleared 510(K)
- K820334NEMECTRODYN MODELS 8,7,5 (VOLS. I-IVCleared 510(K)
- K813098TENS DEVICECleared 510(K)
- K803247TRANSCUTANEOUS ELECT. NERVE STIMULATORCleared 510(K)
- K801606RETREATCleared 510(K)
- K800760BITE BLOCK SYSTEMCleared 510(K)
- K792490UCA LOTIONCleared 510(K)
- K792206MEDTRONIC BURR HOLE PLUG & CAPCleared 510(K)
- K791978SUGITA ANEURYSM CLIPS, APPLIERS & CASECleared 510(K)
- K790883STRESS/EMERGENCY EELCTRODECleared 510(K)
- K781157STIMULATOR, NERVE, TRANSCUTANEOUSCleared 510(K)
- K780706LUMBAR NERVE ROOT SHIELDCleared 510(K)
- 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
- 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
ENCODYNE 4 & VACUFIX 4
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K832393
- 510(k) Type
- Traditional
- Applicant
- ELMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/14/1983
- Days to Decision
- 118 days