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
- 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
- K241639Single-use Video Ureterorenoscope (SVU-220US)2Cleared 510(K)
- K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)2Cleared 510(K)
- K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 22Cleared 510(K)
- K232911KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)2Cleared 510(K)
- K240374Ureterorenoscope System2Cleared 510(K)
- K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)2Cleared 510(K)
- K231135Video Ureteroscope System2Cleared 510(K)
- K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)2Cleared 510(K)
- K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection2Cleared 510(K)
- K230475Medical Video Endoscope System2Cleared 510(K)
- K223097RenaNav Ureteroscope System2Cleared 510(K)
- K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS1012Cleared 510(K)
- K230200Single-Use Flexible Ureteroscope2Cleared 510(K)
- K221158Single-Use Video Flexible Ureterorenoscope System2Cleared 510(K)
- K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS1012Cleared 510(K)
- K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring2Cleared 510(K)
- K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)2Cleared 510(K)
- K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)2Cleared 510(K)
- K213334Monarch Platform, Urology2Cleared 510(K)
- K211686Flexible Video-Choledo-Cysto-Ureteroscope System2Cleared 510(K)
- K212458Flexible Video-Uretero-Renoscope SSU System2Cleared 510(K)
- K211347Uretero1 Ureteroscope System2Cleared 510(K)
- K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System2Cleared 510(K)
- K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 55252Cleared 510(K)
- K200369OES Elite Ureteroscopes and Accessories2Cleared 510(K)
- K201293Ureterorenoscope System2Cleared 510(K)
- K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF2Cleared 510(K)
- K181451URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R2Cleared 510(K)
- K181977WiScope Digital Endoscope System2Cleared 510(K)
- K180367Ureterorenoscope System2Cleared 510(K)
- K172246OLYMPUS URF-V2/V2R2Cleared 510(K)
- K172298OLYMPUS URF-P6/P6R2Cleared 510(K)
- K172098Medical Video Endoscope System2Cleared 510(K)
- K171076Medical Video Endoscope System2Cleared 510(K)
- K153049LithoVue System2Cleared 510(K)
- K142556Flexible Video-Uretero-Choledochoscope System2Cleared 510(K)
- K141250FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM2Cleared 510(K)
- K131369FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM2Cleared 510(K)
- K121112STRYKER VIDEO URETEROSCOPE2Cleared 510(K)
- K111480MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM2Cleared 510(K)
- K062707RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE2Cleared 510(K)
- K062725MAXIFLEX-SEMI FLEX SCOPE2Cleared 510(K)
- K052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL2Cleared 510(K)
- K043021STRYKER URETEROSCOPE2Cleared 510(K)
- K033651OLYMPUS VIDEO URETEROSCOPE, NTSC2Cleared 510(K)
- K031278STRYKER FLEXIBLE URETEROSCOPE2Cleared 510(K)
- K023358USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 82Cleared 510(K)
- K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,2Cleared 510(K)
- K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS2Cleared 510(K)
- K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE2Cleared 510(K)
- K012925DUR-8, MODELS DUR-82Cleared 510(K)
- K011325MEDIFIX URETEROSCOPE2Cleared 510(K)
- K003806URETEROSCOPES2Cleared 510(K)
- K000200CORTEK URETHEROSCOPE2Cleared 510(K)
- K992527URETERO-RENOSCOPE2Cleared 510(K)
- K991178FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.2532Cleared 510(K)
- K990050URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.0422Cleared 510(K)
- K982905MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE2Cleared 510(K)
- K96385512 URETEROSCOPES/URETERO-RENOSCOPES2Cleared 510(K)
- K970427KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE2Cleared 510(K)
- K964482FLEXIBLE URETEROSCOPE2Cleared 510(K)
- K960323KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE2Cleared 510(K)
- K951855ULTRATHIN URETEROSCOPES2Cleared 510(K)
- K941013HMT ALEXCOPE2Cleared 510(K)
- K940464KARL STORZ URETERO-RENOSCOPE/URETERSCOPE2Cleared 510(K)
- K925128THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE2Cleared 510(K)
- K926423S/2(TM) STOPCOCK2Cleared 510(K)
- K926004ENDOSCOPE AND ACCOSSORIES2Cleared 510(K)
- K923545BARD 7 FR. FIBER OPTIC ASSEMBLY2Cleared 510(K)
- K920750BARD URETEROSCOPE DEFLECTION MODULE2Cleared 510(K)
- K915458URETEROSCOPE2Cleared 510(K)
- K914106PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P2Cleared 510(K)
- K911411BARD 3000 PLUS URETEROSCOPY SYSTEM2Cleared 510(K)
- K904793SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)2Cleared 510(K)
- K902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET2Cleared 510(K)
- K901214RIGID URETEROSCOPE2Cleared 510(K)
- K900813BARD SHORT RIGID URETEROSCOPE2Cleared 510(K)
- K884153CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE2Cleared 510(K)
- K883110BARD URETEROSCOPIC DEVICE2Cleared 510(K)
- K880801SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-92Cleared 510(K)
- K880802SURGITEK ARTICULATING URETEROSCOPE MODEL SU-112Cleared 510(K)
- K872282FLEXIBLE URETEROSCOPE2Cleared 510(K)
- K862551FUNS-10, FUNS-112Cleared 510(K)
- K852888OLYMPUS RIGID URETERORENOSCOPE2Cleared 510(K)
- K844143OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE2Cleared 510(K)
- K811535MODEL FUS-1, FLEXIBLE URETEROSCOPE2Cleared 510(K)
- 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
- 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
Monarch Platform, Urology
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213334
- 510(k) Type
- Traditional
- Applicant
- Auris Health Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/29/2022
- Days to Decision
- 205 days
- Submission Type
- Summary