Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- K230287SaviSafe Safety Device2Cleared 510(K)
- K231165Shina Syringe; Shina Safety Syringe2Cleared 510(K)
- K231907Medline Safety Insulin and TB Syringes2Cleared 510(K)
- K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)2Cleared 510(K)
- K220114PowerPAK Syringe2Cleared 510(K)
- K221981SafeR Syringe and SafeR Sting2Cleared 510(K)
- K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)2Cleared 510(K)
- K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle2Cleared 510(K)
- K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization2Cleared 510(K)
- K221073Sterile Hypodermic Syringes for Single Use with Safety Needles2Cleared 510(K)
- K221416Sterile Safety Syringes for Single Use2Cleared 510(K)
- K220061Safety Insulin Syringes2Cleared 510(K)
- K212518Jeesung Safety Syringe and Single Use Needles2Cleared 510(K)
- K220183Sterile Safety Syringes for Single Use (Retractable)2Cleared 510(K)
- K220185Sterile Safety Insulin Syringes for Single Use2Cleared 510(K)
- K213077Automatically Retractable Safety Syringe2Cleared 510(K)
- K210216Disposable Automatically Retractable Insulin Safety Syringe2Cleared 510(K)
- K212652Sterile Syringe with Fixed Safety Needle for Single Use2Cleared 510(K)
- K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles2Cleared 510(K)
- K212949Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use2Cleared 510(K)
- K210229Sterile Auto-Disable Syringes with/without Needle for Single Use2Cleared 510(K)
- K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle2Cleared 510(K)
- K211555Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe2Cleared 510(K)
- K211753Sterile Syringe With Safety Needle2Cleared 510(K)
- K212226DR Safety Syringe, Sterile Hypodermic needle for Single use2Cleared 510(K)
- K202570Insulin Syringe, Insulin Syringe with Safety Retractable2Cleared 510(K)
- K191639TK Insulin Syringe with/without Saftey Retractable Device2Cleared 510(K)
- K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle2Cleared 510(K)
- K193022Retractable Safety Insulin Syringe2Cleared 510(K)
- K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use2Cleared 510(K)
- K190183Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe2Cleared 510(K)
- K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe2Cleared 510(K)
- K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use2Cleared 510(K)
- K173743Greenmedi Safety Filter Syringe2Cleared 510(K)
- K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use2Cleared 510(K)
- K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle2Cleared 510(K)
- K163162Sterile Hypodermic Safety Syringes for Single Use2Cleared 510(K)
- K163511NovaGuard SA Pro Safety System2Cleared 510(K)
- K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed Needle2Cleared 510(K)
- K152606Jeesung Safety Syringe and Single Use Needles2Cleared 510(K)
- K152808U&U Insulin Syringe with/without Safety Retractable Device2Cleared 510(K)
- K143497Safety Auto-Disable Syrine with Needle (Auto-Lock)2Cleared 510(K)
- K143070Disposable Safety Self-destructive Syringes, 5 ML2Cleared 510(K)
- K150562Safe'n'Sound Staked Passive Delivery System - Plajex version2Cleared 510(K)
- K141349Disposable sterile needle retractable safety syringe2Cleared 510(K)
- K1424353S Safety Syringe with/without Needle2Cleared 510(K)
- K1424363S Safety Insulin Syringe2Cleared 510(K)
- K140949ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE2Cleared 510(K)
- K141640AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE2Cleared 510(K)
- K141664SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION2Cleared 510(K)
- K141464NOVAGUARD S A SAFETY SYSTEM2Cleared 510(K)
- K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE2Cleared 510(K)
- K131531TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE2Cleared 510(K)
- K123743ULTRASAFE PLUS PASSIVE NEEDLE GUARD2Cleared 510(K)
- K121637AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE2Cleared 510(K)
- K120641GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K122558ULTRASAFE PASSIVE NEEDLE GUARD2Cleared 510(K)
- K113587AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)2Cleared 510(K)
- K112936SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM2Cleared 510(K)
- K111734MYSAFETY SYRINGE2Cleared 510(K)
- K101560MEDLINE RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K101233SAFE'N'SOUND PASSIVE DELIVERY SYSTEM2Cleared 510(K)
- K103781MED-LOK SAFETY NEEDLE2Cleared 510(K)
- K103011ULTICARE SAFETY INSULIN SYRINGE2Cleared 510(K)
- K1009981ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-12Cleared 510(K)
- K093176MED-LOK2Cleared 510(K)
- K0924301 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES2Cleared 510(K)
- K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES2Cleared 510(K)
- K0808771ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/22Cleared 510(K)
- K080600ULTIMED ULTICARE SAFETY SYRINGE2Cleared 510(K)
- K072739JIERUI SYRINGES AND NEEDLES2Cleared 510(K)
- K073206NEEDLE-TRAP/NEEDLE SAFETY LABEL2Cleared 510(K)
- K072482HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY2Cleared 510(K)
- K072037CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML2Cleared 510(K)
- K070117SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC2Cleared 510(K)
- K070203INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 1300242Cleared 510(K)
- K063340SAF-T-SYRINGE- 0.5 AND 1ML/CC2Cleared 510(K)
- K063755PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE2Cleared 510(K)
- K062780CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE2Cleared 510(K)
- K062318BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML2Cleared 510(K)
- K060971OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS2Cleared 510(K)
- K060772MANUEL SAFTEY SYRINGE PARTS 1 & 22Cleared 510(K)
- K061194PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 4325582Cleared 510(K)
- K053519SAFETY SYRINGE2Cleared 510(K)
- K061055CAREO SAFETY SYRINGE FOR U-100 INSULIN2Cleared 510(K)
- K060668SAFE TIP SYRINGE2Cleared 510(K)
- K060002RITRACT SAFETY SYRINGE2Cleared 510(K)
- K060109OMI RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K060743MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)2Cleared 510(K)
- K060208CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,2Cleared 510(K)
- K052397CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)2Cleared 510(K)
- K051694CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K051800IN6 SAFETY SYRINGE, MODEL 3ML2Cleared 510(K)
- K052103EXEL SECURE TOUCH II SAFETY SYRINGE2Cleared 510(K)
- K051865TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR2Cleared 510(K)
- K051762SAF-T-SYRINGE/SAF-T-NEEDLE2Cleared 510(K)
- K050116UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES2Cleared 510(K)
- K043419P&P SAFETY SYRINGE2Cleared 510(K)
- K050131INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE2Cleared 510(K)
- K050134ICC INSULIN SAFEPRO SAFETY SYRINGE2Cleared 510(K)
- K042102YIXIN SAFETY SYRINGE2Cleared 510(K)
- K042487PROCEDUR SF SAFETY SYRINGE DEVICE2Cleared 510(K)
- K043038BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML2Cleared 510(K)
- K042712TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM2Cleared 510(K)
- K042426TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)2Cleared 510(K)
- K041970BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML2Cleared 510(K)
- K032517MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE2Cleared 510(K)
- K032747BIOTOP DJT-A SAFETY SYRINGE2Cleared 510(K)
- K030604PERFECT SAFETY SYRINGE2Cleared 510(K)
- K040545OTTER SAFETY SYRINGE2Cleared 510(K)
- K040105YUE PFONG SAFETY SYRINGE (3ML)2Cleared 510(K)
- K040036INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 1029052Cleared 510(K)
- K03403110 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K031909BETEC RETRACTABLE SAFETY SYRINGE (5ML)2Cleared 510(K)
- K032247U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K032780INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC2Cleared 510(K)
- K031830SAFEPRO PLUS SAFETY SYRINGE2Cleared 510(K)
- K031163SEZ SAFETY SYRINGE2Cleared 510(K)
- K031065SYRINGEX SAFETY SYRINGE, MODEL 0322G1.52Cleared 510(K)
- K031594BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY2Cleared 510(K)
- K030976CAREO RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K031062TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)2Cleared 510(K)
- K024249TERUMO SURGUARD SAFETY SYRINGE2Cleared 510(K)
- K011754EXEL SECURETOUCH PTP SYRINGE2Cleared 510(K)
- K023458TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)2Cleared 510(K)
- K0233231CC FUTURA SAFETY SYRINGE2Cleared 510(K)
- K022806DUOPRO SAFETY SYRINGE (DUOPROSS)2Cleared 510(K)
- K022278TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)2Cleared 510(K)
- K022063SAFEPRO SAFETY SYRINGE2Cleared 510(K)
- K020623DUOPRO SAFETY SYRINGE (DUOPROSS)2Cleared 510(K)
- K013006OVUS CAPLESS SAFETY NEEDLE2Cleared 510(K)
- K013801ULTRASAFE DENTAL INJECTION SYSTEM2Cleared 510(K)
- K0108193CC NMT SAFETY SYRINGE2Cleared 510(K)
- K012121SECUREGUARD RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K012726PROSAFE SAFETY SYRINGE2Cleared 510(K)
- K010477AUTO-LOCK2Cleared 510(K)
- K003555SOLO-SAFE SAFETY SYRINGE, SIZE-3CC2Cleared 510(K)
- K011103BD SPRING BASED SYRINGE2Cleared 510(K)
- K011369ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)2Cleared 510(K)
- K003348E.N.S.I. RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K993996UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE2Cleared 510(K)
- K000860FUTURA SAFETY SYRINGE2Cleared 510(K)
- K001017RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC2Cleared 510(K)
- K993609SOLOGUARD LOCKING PLUS SYRINGE2Cleared 510(K)
- K990831SUPERGUARD SAFETY SYRINGE2Cleared 510(K)
- K000572E.N.S.I. SYRINGE2Cleared 510(K)
- K992734BECTON DICKINSON SYRINGE2Cleared 510(K)
- K990208PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT2Cleared 510(K)
- K982431NMT SAFETY SYRINGE2Cleared 510(K)
- K973888SMARTLOCK SAFETY SYRINGE2Cleared 510(K)
- K971077COVERTIP SAFETY SYRINGE2Cleared 510(K)
- K980069VANISHPOINT SYRINGE2Cleared 510(K)
- K973792EASYSAFE RETRACTING NEEDLE SYRINGE2Cleared 510(K)
- K973301ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE2Cleared 510(K)
- K970803ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE2Cleared 510(K)
- K933469UNIVEC NON-REUSABLE SYRINGE2Cleared 510(K)
- K946219POP-N-LOK SYRINGE2Cleared 510(K)
- K955030SQUARE ONE SAFETY SYRINGE2Cleared 510(K)
- K933569PENT NOVA AUTOBLOCK SYRINGE2Cleared 510(K)
- K936225TS1 TURTLE(TM) SYRINGE2Cleared 510(K)
- K936040HYPO(R) SAFETY CARTRIDGE SYRINGE2Cleared 510(K)
- K944425ULTRASAFE ASPIRATING SYRINGE2Cleared 510(K)
- K941450INVIRO SYRINGE2Cleared 510(K)
- K925039SAFESNAP SAFETY SYRINGE2Cleared 510(K)
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192679
- 510(k) Type
- Traditional
- Applicant
- Gemtier Medical (Shanghai) Inc.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/10/2020
- Days to Decision
- 197 days
- Submission Type
- Summary