Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic 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
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- K241410EDEN ControlCath2Cleared 510(K)
- K231242Perifix FX Catheter; Contiplex FX Catheter2Cleared 510(K)
- K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)2Cleared 510(K)
- K193664SubQKath Catheter and Needle Set2Cleared 510(K)
- K200624Percutaneous Introducer2Cleared 510(K)
- K191470C-CAT Anaesthesia Catheter kit2Cleared 510(K)
- K181782Medline Reinforced Epidural Catheter2Cleared 510(K)
- K173541EPINAUT2Cleared 510(K)
- K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-72Cleared 510(K)
- K171584B. Braun Tear-Away Introducer Needle2Cleared 510(K)
- K171193Certa Catheter2Cleared 510(K)
- K162522UltraCath Continuous Nerve block Catheter2Cleared 510(K)
- K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit2Cleared 510(K)
- K153297Perifix and Contiplex Catheter2Cleared 510(K)
- K152952E-Cath2Cleared 510(K)
- K150731Medline Epidural Catheter2Cleared 510(K)
- K150789SPINAUT-E, SPINAUT-I2Cleared 510(K)
- K140110FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET2Cleared 510(K)
- K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set2Cleared 510(K)
- K133316SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)2Cleared 510(K)
- K122661VITAL 5 RELEAF CATHETER2Cleared 510(K)
- K111031PAINFUSOR CATHETER2Cleared 510(K)
- K110814AMBIT TUNNELER2Cleared 510(K)
- K102594IO-FLEX CATHETER2Cleared 510(K)
- K102460AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH2Cleared 510(K)
- K093920BUSSE EPIDURAL CATHETER KIT2Cleared 510(K)
- K090884PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.2Cleared 510(K)
- K081404SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT2Cleared 510(K)
- K080675PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT2Cleared 510(K)
- K072702STRYKER ANTIMIC CATHETER2Cleared 510(K)
- K072050PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS2Cleared 510(K)
- K070465BUSSE EPIDURAL CATHETER2Cleared 510(K)
- K063234ON-Q INTRODUCERS2Cleared 510(K)
- K062005PORTEX EPIDURAL CATHETER2Cleared 510(K)
- K051401ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER2Cleared 510(K)
- K051524LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/2162Cleared 510(K)
- K050557AMT NANOCATH2Cleared 510(K)
- K043456MODIFICATION TO SOAKER CATHETER2Cleared 510(K)
- K042488PERIFIX CATHETER AND CONTIPLEX CATHETER2Cleared 510(K)
- K032390MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM2Cleared 510(K)
- K023140VERSA-KATH EPIDURAL CATHETER, MODEL 156-21242Cleared 510(K)
- K023233EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM2Cleared 510(K)
- K022019PERIFIX CATHETER CONNECTOR2Cleared 510(K)
- K991259TE ME NA EPIDURAL CATHETER2Cleared 510(K)
- K000886SPIROL EPIDURAL CATHETER2Cleared 510(K)
- K001717MICOR CONDUCTION CATHETER2Cleared 510(K)
- K993592AXIOM MULTIPURPOSE WOUND DRAIN2Cleared 510(K)
- K991879SPRING-WOUND EPIDURAL CATHETER2Cleared 510(K)
- K992471SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-182Cleared 510(K)
- K981329FETH-R-KATH2Cleared 510(K)
- K971851INTERPLEURAL ANESTHESIA CATHETER2Cleared 510(K)
- K951927COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)2Cleared 510(K)
- K954584RACZ EPIDURAL CATHETER2Cleared 510(K)
- K951092CATHETER SECUREMENT DEVICE2Cleared 510(K)
- K935927CONCORD/PORTEX EPIDURAL CATHETERS2Cleared 510(K)
- K930539MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY2Cleared 510(K)
- K930219KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE2Cleared 510(K)
- K9249954 SURE TM ANESTHESIA EXTENSION SET2Cleared 510(K)
- K922113KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH2Cleared 510(K)
- K897194PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL2Cleared 510(K)
- K896712PHARMASEAL EPIDURAL CATHETER2Cleared 510(K)
- K901129BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER2Cleared 510(K)
- K895204EPI-CATH(TM) EPIDURAL CATHETER2Cleared 510(K)
- K884969BIO-MATE(TM) EPIDURAL CATHETER2Cleared 510(K)
- K863792DURACATH, GISH MODEL NO. DVAC-XXXX2Cleared 510(K)
- K854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH2Cleared 510(K)
- K850009EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER2Cleared 510(K)
- K850505DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER2Cleared 510(K)
- K850439DESERET EPIDURAL CATHETER2Cleared 510(K)
- K840202EPIDURAL CATHETER2Cleared 510(K)
- K8323523-DAY RELEASE OF ETHYLENE OXIDE DEVICE2Cleared 510(K)
- K832232EPINEED EPIDURAL CATHETER2Cleared 510(K)
- K823702EPIDURAL CATHETER2Cleared 510(K)
- K822436DNA MEDICAL DURACATH2Cleared 510(K)
- K802065CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG2Cleared 510(K)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- CAFNebulizer (Direct Patient Interface)2Product Code
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- SDSCompression-Based Airway Clearance Device2Product Code
- SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices2Product Code
- SFPVentilator-Compatible Nebulizer2Product Code
- Subpart G—MiscellaneousCFR Sub-Part
- 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
- 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
SPINAUT-E, SPINAUT-I
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150789
- 510(k) Type
- Traditional
- Applicant
- IMEDICOM CO., LTD.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/1/2016
- Days to Decision
- 342 days
- Submission Type
- Summary