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
- 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
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- K243232GripMate2Cleared 510(K)
- K213429AccuSert Needle Inserter2Cleared 510(K)
- K163400Orbit Inserter2Cleared 510(K)
- K160860MiniMed Quick-serter2Cleared 510(K)
- K141384WHISPERJECT AUTOINJECTOR2Cleared 510(K)
- K124026LOBSTER AUTO-INJECTOR2Cleared 510(K)
- K122837AUTOJECT 2 FOR GLASSY SYRINGE2Cleared 510(K)
- K111467FLEXI-Q DV AND DVR AUTO-INJECTORS2Cleared 510(K)
- K082587AUTO-SAFETY INJECTOR-2 (ASI-2)2Cleared 510(K)
- K073476COMPACT AUTO-SAFETY INJECTOR (CASI)2Cleared 510(K)
- K062339DERMOTHERAP GUN2Cleared 510(K)
- K063146ACCU-CHEK LINKASSIST2Cleared 510(K)
- K060141DAI-R2Cleared 510(K)
- K060389CONFIDOSE IM AUTO-INJECTOR2Cleared 510(K)
- K051667EZ-JECT2Cleared 510(K)
- K050434SHL DISPOSABLE AUTOINJECTOR2Cleared 510(K)
- K033696PERSONAL INJECTOR2Cleared 510(K)
- K042557INNOJECT AUTO-INJECTOR2Cleared 510(K)
- K032848MEDSAFE SYSTEM INSERTER2Cleared 510(K)
- K032425INVISIJECT RESUSABLE AUTO-INJECTOR2Cleared 510(K)
- K021700ANIMUS EZSERTER INFUSION SET INSERTER2Cleared 510(K)
- K013362AUTOJECT 22Cleared 510(K)
- K010377MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 3852Cleared 510(K)
- K000482MODIFICATION TO AUTOJECT MINI2Cleared 510(K)
- K993385AUTOJET 2 (NON-FIXED NEEDLE TYPE)2Cleared 510(K)
- K992300QUICK-SERTER, MODEL 3952Cleared 510(K)
- K991680SOFTINJECT2Cleared 510(K)
- K981266AUTO-INJECTOR, SURE-INJECT 20002Cleared 510(K)
- K974678B-D AUTO-INJECTOR2Cleared 510(K)
- K974171COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS2Cleared 510(K)
- K970479MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 3002Cleared 510(K)
- K961309POS-T-VAC ID-3002Cleared 510(K)
- K954729PEN-INJECT 2.252Cleared 510(K)
- K953735AUTOJECT MINI2Cleared 510(K)
- K945660AUTOJECT 22Cleared 510(K)
- K951384V-CATH PERCUTANEOUS INTRODUCER KIT2Cleared 510(K)
- K945473V-CATH BREAKAWAY NEEDLE INTRODUCER2Cleared 510(K)
- K901803SYRINGE NEEDLE INTRODUCER2Cleared 510(K)
- K883164INSTAJECT II2Cleared 510(K)
- K872233INJECT-EASE2Cleared 510(K)
- K870474INSTAJECT2Cleared 510(K)
- K862325THE INJECTOR2Cleared 510(K)
- K860284DIAMATIC, AUTOMATIC INSULIN INJECTOR2Cleared 510(K)
- K832847MEDI-JECT2Cleared 510(K)
- K834440INJECTION AIDE UNIT FOR DIAGETICS2Cleared 510(K)
- K832683MONOJECT INJECTOMATIC2Cleared 510(K)
- K790104PISTORMATIC2Cleared 510(K)
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- 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
SOFTINJECT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K991680
- 510(k) Type
- Traditional
- Applicant
- ANDROSYSTEMS SRL
- Country
- Italy
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/3/1999
- Days to Decision
- 17 days
- Submission Type
- Summary