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
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- K162566AIK Sterile Acupuncture Needles for Single Use2Cleared 510(K)
- K142760Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles2Cleared 510(K)
- K150903EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural2Cleared 510(K)
- K142920KM Needles (Acupuncture Needle)2Cleared 510(K)
- K141473SMC ACUPUNCTURE NEEDLE2Cleared 510(K)
- K132896CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE2Cleared 510(K)
- K111392WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)2Cleared 510(K)
- K103061BIOMATE STERILE ACUPUNCTURE NEEDLE2Cleared 510(K)
- K092240ACUPUNCTURE NEEDLES2Cleared 510(K)
- K090199JIAJIAN ACUPUNCTURE NEEDLE2Cleared 510(K)
- K090910HANSO ACUPUNCTURE NEEDLE2Cleared 510(K)
- K071524TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL2Cleared 510(K)
- K072778BRIO ACUPUNCTURE NEEDLES2Cleared 510(K)
- K061517PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES2Cleared 510(K)
- K062448LYRA ACUPUNCTURE NEEDLES2Cleared 510(K)
- K060392ASP TITANIUM2Cleared 510(K)
- K052731KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- K052723SEVEN STAR NEEDLE2Cleared 510(K)
- K052846TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE2Cleared 510(K)
- K052085STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES2Cleared 510(K)
- K050295PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES2Cleared 510(K)
- K043506ACUPUNCTURE NEEDLES2Cleared 510(K)
- K043277C&G ACUPUNCTURE NEEDLE2Cleared 510(K)
- K041652ACUPUNCTURE NEEDLES2Cleared 510(K)
- K042063PRESS TACK NEEDLE2Cleared 510(K)
- K031818FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE2Cleared 510(K)
- K031250DBC PRESS ACUPUNCTURE NEEDLES2Cleared 510(K)
- K031060NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES2Cleared 510(K)
- K031716SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE2Cleared 510(K)
- K024207VINCO BRAND ACUPUNCTURE NEEDLE2Cleared 510(K)
- K030190CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- K023787TAI-CHI AND MASTER ACUPUNCTURE NEEDLES2Cleared 510(K)
- K023054JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE2Cleared 510(K)
- K021904MAEDA SILVER ACUPUNCTURE NEEDLE2Cleared 510(K)
- K013926QIZHOU ACUPUNCTURE NEEDLE2Cleared 510(K)
- K020880MARKNEW PRODUCTS ACUPUNCTURE NEEDLES2Cleared 510(K)
- K021095HOLY DRAGON BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- K012583ACUGLIDE BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- K012501H.M.T. ACUPUNCTURE NEEDLE2Cleared 510(K)
- K011248CW DISPOSABLE ACUPUNCTURE NEEDLE2Cleared 510(K)
- K011247HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE2Cleared 510(K)
- K011242HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE2Cleared 510(K)
- K011808ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)2Cleared 510(K)
- K011669BW ACUPUNCTURE NEEDLES2Cleared 510(K)
- K002827MAC ACUPUNCTURE NEEDLE2Cleared 510(K)
- K000581MAEDA NEW NEEDLE DISPOSABLE2Cleared 510(K)
- K002910HOLY DRAGON ACUPUNCTURE NEEDLES2Cleared 510(K)
- K003760TAI-CHI ACUPUNCTURE NEEDLES2Cleared 510(K)
- K003748TIANXIE2Cleared 510(K)
- K002411SHENLING ACUPUNCTURE NEEDLES2Cleared 510(K)
- K003010SPIRIT ACUPUNCTURE NEEDLE2Cleared 510(K)
- K001718MILLENNIA ACUPUNCTURE NEEDLE2Cleared 510(K)
- K000816SHARP BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- K000740ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S2Cleared 510(K)
- K991508ACUMASTER BRAND ACUPUNCTURE NEEDLE2Cleared 510(K)
- K991507KANGNIAN BRAND ACUPUNCTURE NEEDLE2Cleared 510(K)
- K983798SEDATELEC ASP ACUPUNCTURE NEEDLES2Cleared 510(K)
- K983800DN ACUPUNTURE NEEDLES2Cleared 510(K)
- K990729FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES2Cleared 510(K)
- K990328DBC, DONG BANG ACUPUNCTURE NEEDLES2Cleared 510(K)
- K990406KINGLI ACUPUNCTURE NEEDLE2Cleared 510(K)
- K983671NATURAL BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- K981272ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES2Cleared 510(K)
- K980899JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID2Cleared 510(K)
- K980471KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE2Cleared 510(K)
- K980472KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE2Cleared 510(K)
- K980470KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE2Cleared 510(K)
- K980469KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE2Cleared 510(K)
- K974616SINGER ACUPUNCTURE NEEDLES2Cleared 510(K)
- K974122ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA2Cleared 510(K)
- K974527KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE2Cleared 510(K)
- K972658MAGI ACUPUNCTURE NEEDLES2Cleared 510(K)
- K972659DONG BANG ACUPUNCTURE NEEDLES2Cleared 510(K)
- K964861ACUPUNCTURE NEEDLES2Cleared 510(K)
- K970574ACUPUNCTURE NEEDLES2Cleared 510(K)
- K970260SEIRIN JR ACUPUNCTURE NEEDLES2Cleared 510(K)
- K970254SEIRIN PYONEX ACUPUNCTURE NEEDLES2Cleared 510(K)
- K964529CW ACUPUNCTURE NEEDLES2Cleared 510(K)
- K964411TAKI ACUPUNCTURE NEEDLES2Cleared 510(K)
- K964051NEEDLE, ACUPUNCTURE2Cleared 510(K)
- K961677ACUPUNCTURE NEEDLES2Cleared 510(K)
- K963769SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES2Cleared 510(K)
- K963299HWA-TO ACUPUNCTURE NEEDLES2Cleared 510(K)
- K963300DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)2Cleared 510(K)
- K963194ITO ACUPUNCTURE NEEDLES2Cleared 510(K)
- K962916HUA-XIA ACUPUNCTURE NEEDLES2Cleared 510(K)
- K962809SEIRIN ACUPUNCTURE NEEDLES2Cleared 510(K)
- K962787TAKI DISPOSABLE ACUPUNCTURE NEEDLE2Cleared 510(K)
- K962419CW-DISPOSABLE ACUPUNCTURE NEEDLE2Cleared 510(K)
- K960769ACUPUNCTURE NEEDLE PACK2Cleared 510(K)
- K961339CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES2Cleared 510(K)
- 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
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K031818
- 510(k) Type
- Traditional
- Applicant
- FACILAI ENTERPRISES LTD.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/3/2003
- Days to Decision
- 174 days
- Submission Type
- Statement