Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- FCPBox, Battery, Pocket1Product Code
- FCQLight Source, Incandescent, Diagnostic2Product Code
- EXQCystometer, Electrical Recording2Product Code
- EXRUrinometer, Mechanical2Product Code
- EXSUrinometer, Electrical2Product Code
- EXWPill, Radio2Product Code
- EXYUroflowmeter2Product Code
- EXZEquipment, Photographic, For Physiologic Function Monitor1Product Code
- FAJCystoscope And Accessories, Flexible/Rigid2Product Code
- FAKPanendoscope (Gastroduodenoscope)2Product Code
- FALPanendoscope (Urethroscope)2Product Code
- FAMSigmoidoscope And Accessories, Flexible/Rigid2Product Code
- FANSigmoidoscope, Rigid, Electrical2Product Code
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device2Product Code
- FBIRongeur, Cystoscopic2Product Code
- FBKEndoscopic Injection Needle, Gastroenterology-Urology2Product Code
- FBNCholedochoscope And Accessories, Flexible/Rigid2Product Code
- FBOCystourethroscope2Product Code
- FBPTelescope, Rigid, Endoscopic2Product Code
- FCCEndoscopic Magnetic Retriever2Product Code
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal2Product Code
- FCGBiopsy Needle2Product Code
- K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)2Cleared 510(K)
- K250994ClearTip FNA and FNB Types2Cleared 510(K)
- K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)2Cleared 510(K)
- K231422Precision GI2Cleared 510(K)
- K231267ClearTip2Cleared 510(K)
- K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)2Cleared 510(K)
- K212423EndoDrill® Model X2Cleared 510(K)
- K212819Disposable Biopsy Refill Needle2Cleared 510(K)
- K212822Disposable Coaxial Biopsy Needle2Cleared 510(K)
- K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle2Cleared 510(K)
- K191472Biopsy Needle2Cleared 510(K)
- K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle2Cleared 510(K)
- K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N2Cleared 510(K)
- K180363Clear-Tip EUS-FNA2Cleared 510(K)
- K181994Single Use Aspiration Needle NA-U201H2Cleared 510(K)
- K180449Single Use Aspiration Needle NA-U200H2Cleared 510(K)
- K180037Beacon EUS Access System2Cleared 510(K)
- K171956Sterile Endoscope Biopsy Sampling Needle2Cleared 510(K)
- K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle2Cleared 510(K)
- K160890Howell Biliary Introducer Needle2Cleared 510(K)
- K160423Perineologic Access Needle2Cleared 510(K)
- K160098Single Use Aspiration Needle NA-U401SX2Cleared 510(K)
- K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle2Cleared 510(K)
- K151738Single Use Aspiration Needle NA-U200H2Cleared 510(K)
- K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle2Cleared 510(K)
- K151373Corvocet Coaxial Introducer2Cleared 510(K)
- K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System2Cleared 510(K)
- K142688Echotip Procore HD Ultrasound Biopsy Needle2Cleared 510(K)
- K131925HS NOTA2Cleared 510(K)
- K141894SHARKCORE FINE NEEDLE BIOPSY SYSTEM2Cleared 510(K)
- K133763SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM2Cleared 510(K)
- K140137SAFETY BIOPSY NEEDLE SYSTEM2Cleared 510(K)
- K133008BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,2Cleared 510(K)
- K103694TISSUE SAMPLING NEEDLE2Cleared 510(K)
- K103668BNX FINE NEEDLE ASPIRATION SYSTEM2Cleared 510(K)
- K100712RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE2Cleared 510(K)
- K093195ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O2Cleared 510(K)
- K092359ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A2Cleared 510(K)
- K091257MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM2Cleared 510(K)
- K083802SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-0252Cleared 510(K)
- K083330ECHOTIP ULTRA ULTRASOUND NEEDLE2Cleared 510(K)
- K081323BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 88182Cleared 510(K)
- K073399TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE2Cleared 510(K)
- K062979THYROSAMPLER2Cleared 510(K)
- K070179TROKABONE, TROKABONE STERNAL2Cleared 510(K)
- K070129SONOTIP II ULTRASOUND NEEDLE SYSTEM2Cleared 510(K)
- K051506MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY2Cleared 510(K)
- K050135K-C HEMOSTATIC BIOPSY SYSTEM2Cleared 510(K)
- K051247SONOTIP II ULTRASOUND NEEDLE SYSTEM2Cleared 510(K)
- K050503SINGLE USE ASPIRATION NEEDLE NA-201SX-40222Cleared 510(K)
- K050120EASY CORE BIOPSY SYSTEM II2Cleared 510(K)
- K040893EASY CORE BIOPSY SYSTEM2Cleared 510(K)
- K024120MODIFICATION TO TEMNO BIOPSY NEEDLES2Cleared 510(K)
- K023272DISPOSABLE ASPIRATION NEEDLE NA-200H2Cleared 510(K)
- K021847BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES2Cleared 510(K)
- K021525TOPCUT2Cleared 510(K)
- K013109SONOPSY2Cleared 510(K)
- K013071SECURCUT ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K013069BIOSPEED2Cleared 510(K)
- K013070JAMSHIDI BIOPSY NEEDLE2Cleared 510(K)
- K012864INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 18362Cleared 510(K)
- K013356WILSON-COOK ULTRASOUND BIOPSY NEEDLE2Cleared 510(K)
- K012358CHIBA NEEDLE2Cleared 510(K)
- K011075EASYBELL2Cleared 510(K)
- K011270AUTOMATED CORE BIOPSY DEVICE2Cleared 510(K)
- K002947BIOMOL ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K002944PRECISA BIOPSY NEEDLE2Cleared 510(K)
- K002946SILENT BIOPSY NEEDLE2Cleared 510(K)
- K991672OLYMPUS NA-10J-KB ASPIRATION NEEDLE2Cleared 510(K)
- K990220MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM2Cleared 510(K)
- K983218N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE2Cleared 510(K)
- K981889WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE2Cleared 510(K)
- K963565MRI NEEDLES2Cleared 510(K)
- K971842COAXIAL NEEDLE2Cleared 510(K)
- K970563OLYMPUS NA-10J-1 ASPIRATION NEEDLE2Cleared 510(K)
- K963894SMARTGUIDE2Cleared 510(K)
- K961897WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K962570ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K962569BIOMID BONE MARROW BIOPSY NEEDLE2Cleared 510(K)
- K962568ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES2Cleared 510(K)
- K962905TX BIOPSY NEEDLE2Cleared 510(K)
- K961185DAUM BIOPSYNEEDLE2Cleared 510(K)
- K960317LAURUS NEEDLE CORE BIOPSY SYSTEM2Cleared 510(K)
- K9433043D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY2Cleared 510(K)
- K951421GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES2Cleared 510(K)
- K954596PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM2Cleared 510(K)
- K954231AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT2Cleared 510(K)
- K954155GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K941722FNA BIOPSY NEEDLE2Cleared 510(K)
- K951598PRO-B BIOPSY NEEDLE2Cleared 510(K)
- K950982B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE2Cleared 510(K)
- K950810RUTNER BIOPSY DEVICE2Cleared 510(K)
- K935844GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA2Cleared 510(K)
- K945813BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP2Cleared 510(K)
- K945921ECHO STAR NEEDLE SET2Cleared 510(K)
- K945146CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K944944CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE2Cleared 510(K)
- K945133MODIFIED BIOPSY NEEDLE2Cleared 510(K)
- K941563THE BIOPSY TOOL2Cleared 510(K)
- K934256GLOBAL MEDICAL CUTTING BIOPSY NEEDLE2Cleared 510(K)
- K936194COAXIAL BIOPSY NEEDLE2Cleared 510(K)
- K915801BIP-COAX-SYSTEM2Cleared 510(K)
- K934370BIP BIOPSY NEEDLE MODIFICATION2Cleared 510(K)
- K934356WILSON-COOK GI ASPIRATION NEEDLE2Cleared 510(K)
- K926559PROACT BIOPSY NEEDLE ENCHANCEMENTS2Cleared 510(K)
- K924271CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES2Cleared 510(K)
- K914732CORE MEDICAL BIOPSY NEEDLE2Cleared 510(K)
- K910720BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER2Cleared 510(K)
- K911397HYPODERMIC NEEDLES, SINGLE LUMEN2Cleared 510(K)
- K905556HIGH SPEED CORE CUT BIOPSY GUN2Cleared 510(K)
- K902320BAUER FLEXI-TEMNO BIOPSY NEEDLE2Cleared 510(K)
- K902319BAUER TEMNO BIOPSY NEEDLE2Cleared 510(K)
- K896932INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE2Cleared 510(K)
- K895725BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES2Cleared 510(K)
- K895897MANAN PROSTATIC BIOPSY NEEDLE2Cleared 510(K)
- K892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILE2Cleared 510(K)
- K891777PRO-CUT BIOPSY NEEDLE2Cleared 510(K)
- K890327BIOPSY NEEDLE GUIDE ATTACHMENT2Cleared 510(K)
- K890203ADMS BIOPSY NEEDLE2Cleared 510(K)
- K882549ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.2Cleared 510(K)
- K871467BIOPSY NEEDLE GUIDE KIT, STERILE2Cleared 510(K)
- K854404ROTEX SCREW BIOPSY NEEDLE2Cleared 510(K)
- K854289MEDSURG ULTRASOUND BIOPSY TRAY2Cleared 510(K)
- K844993COHEN-WARNER TESTICULAR BIOPSY TRAY 2N27202Cleared 510(K)
- K840144YAG LASER 8000 GASTROINTESTINAL BLEE2Cleared 510(K)
- K840354MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE2Cleared 510(K)
- K840168WESTERMAN-JENSEN BIOPSY NEEDLE2Cleared 510(K)
- K840157MILLEREISEN CURVED BIOPSY NEEDLE2Cleared 510(K)
- K834249MONOJECT SOFT TISSUE BIOPSY NEEDLE2Cleared 510(K)
- K800416ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)2Cleared 510(K)
- K800420ADT PERCUTANEOUS NON-DISP. NEEDLE2Cleared 510(K)
- K800419ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL2Cleared 510(K)
- K771108NEEDLE, CHIBA UNIVERSITY2Cleared 510(K)
- FCIPunch, Biopsy2Product Code
- FCKInstrument, Biopsy, Suction2Product Code
- FCLForceps, Biopsy, Non-Electric1Product Code
- FCOBox, Battery, Rechargeable1Product Code
- FCRLight Source, Photographic, Fiberoptic2Product Code
- FCWLight Source, Fiberoptic, Routine2Product Code
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope2Product Code
- FCYBulb, Inflation, For Endoscope1Product Code
- FCZTube, Smoke Removal, Endoscopic1Product Code
- FDAEnteroscope And Accessories2Product Code
- FDCResectoscope, Working Element2Product Code
- FDELaparoscopy Kit2Product Code
- FDFColonoscope And Accessories, Flexible/Rigid2Product Code
- FDRSphyncteroscope2Product Code
- FDSGastroscope And Accessories, Flexible/Rigid2Product Code
- FDTDuodenoscope And Accessories, Flexible/Rigid2Product Code
- FDWEsophagoscope, Rigid, Gastro-Urology2Product Code
- FDXEndoscopic Cytology Brush2Product Code
- FDYDevice, Measuring, For Panendoscope1Product Code
- FDZAttachment, Eyepiece, For Insertion Of Prescription Lens1Product Code
- FEAAttachment, Teaching, For Endoscope1Product Code
- FECObturator, For Endoscope2Product Code
- FEDEndoscopic Access Overtube, Gastroenterology-Urology2Product Code
- FEIInstrument, Special Lens, For Endoscope1Product Code
- FEJAttachment, Binocular, For Endoscope1Product Code
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)1Product Code
- FENDevice, Cystometric, Hydraulic2Product Code
- FEQPump, Air, Non-Manual, For Endoscope2Product Code
- FERAnoscope And Accessories2Product Code
- FESRecorder, External, Pressure, Amplifier & Transducer2Product Code
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- FFFCover, Biopsy Forceps1Product Code
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable2Product Code
- FFSImage, Illumination, Fiberoptic, For Endoscope2Product Code
- FFTElectrode, Ph, Stomach1Product Code
- FFXSystem, Gastrointestinal Motility (Electrical)2Product Code
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope1Product Code
- FFZCord, Electric, For Endoscope2Product Code
- FGAKit, Nephroscope2Product Code
- FGBUreteroscope And Accessories, Flexible/Rigid2Product Code
- FGCUrethroscope2Product Code
- FGSCarrier, Sponge, Endoscopic2Product Code
- FHOPneumoperitoneum Needle2Product Code
- FHPNeedle, Pneumoperitoneum, Simple2Product Code
- FHXJelly, Lubricating, For Transurethral Surgical Instrument2Product Code
- FJLResectoscope2Product Code
- FTILamp, Endoscope, Incandescent2Product Code
- FTJColonoscope, General & Plastic Surgery2Product Code
- GCFProctoscope2Product Code
- GCKGastroscope, General & Plastic Surgery2Product Code
- GCLEsophagoscope, General & Plastic Surgery2Product Code
- GCMEndoscope, Rigid2Product Code
- GCNEndoscope, Prism2Product Code
- GCOEndoscope, Mirror2Product Code
- GCPEndoscope, Ac-Powered And Accessories2Product Code
- GCQEndoscope, Flexible2Product Code
- GCSEndoscope, Battery-Powered And Accessories2Product Code
- GCTLight Source, Endoscope, Xenon Arc2Product Code
- GCWTransformer, Endoscope2Product Code
- GDBEndoscope, Fiber Optic2Product Code
- KDMSigmoidoscope, Rigid, Non-Electrical2Product Code
- KDORongeur, Cystoscopic, Hot2Product Code
- KGDScissors For Cystoscope2Product Code
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2Product Code
- KNWInstrument, Biopsy2Product Code
- MNKEndoscopic Bite Block1Product Code
- MNLAccessories, Cleaning Brushes, For Endoscope1Product Code
- MYESystem, Electrogastrography (Egg)2Product Code
- NBGMarker, Colon2Product Code
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule2Product Code
- NLMLaparoscope, General & Plastic Surgery, Reprocessed2Product Code
- NLSInstrument, Biopsy, Reprocessed2Product Code
- NLXNeedle, Pneumoperitoneum, Spring Loaded, Reprocessed2Product Code
- NMXNeedle And Needle Set, Gastro-Urology, Reprocessed2Product Code
- NMYNeedle, Endoscopic, Reprocessed2Product Code
- NONForceps, Biopsy, Non-Electric, Reprocessed1Product Code
- NSISystem, Imaging, Esophageal, Wireless, Capsule2Product Code
- NTNLed Light Source2Product Code
- NWBEndoscope, Accessories, Narrow Band Spectrum2Product Code
- NYVGastrointestinal Motility System, Capsule2Product Code
- NWSKit, Choledochoscope, Flexible And Rigid2Product Code
- NWTEndoscopic Cholangiogram Kit2Product Code
- NWUEndoscope Introducer Kit2Product Code
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- OCTAnti Fog Solution And Accessories, Endoscopy2Product Code
- OCUEndoscopic Storage Cover2Product Code
- OCVEndoscope Holder2Product Code
- OCWEndoscopic Tissue Approximation Device2Product Code
- OCXEndoscopic Irrigation/Suction System2Product Code
- OCYEndoscopic Guidewire, Gastroenterology-Urology2Product Code
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered2Product Code
- ODAEndoscopic Central Control Unit2Product Code
- ODBEndoscopic Contamination Prevention Sheath2Product Code
- ODCEndoscope Channel Accessory2Product Code
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula2Product Code
- ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)2Product Code
- ODFMini Endoscope, Gastroenterology-Urology2Product Code
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology2Product Code
- PCVEndoscopic Leak Tester2Product Code
- PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement2Product Code
- PGDColon Capsule Imaging System2Product Code
- PGUSpatial Imaging For Display Of Endoscope Position2Product Code
- PHTBasin For Endoscope Reprocessing1Product Code
- PLLSubmucosal Injection Agent2Product Code
- POZBiopsy Needle Kit2Product Code
- PPENephroscope Set2Product Code
- PRVGastro-Urology Biopsy Kit2Product Code
- PTQEndoscopic Magnetic Retriever, Exempt2Product Code
- QFZGastroenterology-Urology Accessories To A Biopsy Instrument1Product Code
- PTRScissors For Cytoscope, Exempt2Product Code
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt2Product Code
- QIJEndoscopic Transhepatic Venous Access Needle2Product Code
- QISEsophageal, Mucosal, Electrical Characterization2Product Code
- QKZMagnetically Maneuvered Capsule Endoscopy System2Product Code
- QNPGastrointesinal Lesion Software Detection System2Product Code
- SBXSoftware For Endoscopy Procedure Metrics2Product Code
- SGHUltrasound Imaging For Vascular Access For Hemodialysis2Product Code
- Subpart B—Obstetrical and Gynecological 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—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical 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
- 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
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150891
- 510(k) Type
- Special
- Applicant
- Covidien LLC( Formerly Beacon Endoscopic Corp.)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/1/2015
- Days to Decision
- 29 days
- Submission Type
- Summary