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
- K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODE2Cleared 510(K)
- K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE2Cleared 510(K)
- K963330URODYNAMIC ANALYSIS MODULE2Cleared 510(K)
- K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER2Cleared 510(K)
- K931175SCHUSTER DISPOSABLE BALLOON PROBE2Cleared 510(K)
- K931179UROLAB SPECTRUM2Cleared 510(K)
- K922476URO-PRO 20002Cleared 510(K)
- K924383SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO2Cleared 510(K)
- K923995URODYNAMICS TUBING KITS #5161, #5150, #71702Cleared 510(K)
- K923464URODYNAMIC CATHETERS2Cleared 510(K)
- K924086NICKI, MODEL NUMBER USD-NK-UP12Cleared 510(K)
- K920451ENDOTEK ULTRA SYSTEM2Cleared 510(K)
- K920777LABORIE URODYNAMICS PROCESSOR2Cleared 510(K)
- K920575MERKUR 40002Cleared 510(K)
- K914300PHOENIX 5 URODYNAMICS SYSTEM2Cleared 510(K)
- K921047MODEL 8100 URODYNAMICS MEASURING SYSTEM2Cleared 510(K)
- K920992PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED2Cleared 510(K)
- K920991IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION2Cleared 510(K)
- K915484URETHRALPRESSURE PROFILE CATHETER2Cleared 510(K)
- K915443URODYNAMIC CATHETER2Cleared 510(K)
- K913736DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST2Cleared 510(K)
- K913169DANTEC UD 5500 MK22Cleared 510(K)
- K914891PULLER OPTION FOR ETUDE(TM)2Cleared 510(K)
- K912701DANTEC MENUET2Cleared 510(K)
- K912451URODYNAMIC RECTAL BALLOON2Cleared 510(K)
- K913323ETUDE (MODEL NUMBERS 24A05 & 24A06)2Cleared 510(K)
- K911125DIAGNOSTIC ULTRASOUND/URO-GYN UPS 20202Cleared 510(K)
- K911091DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES2Cleared 510(K)
- K910444BROWNE MEDICAL SYSTEMS IMAGEPRO2Cleared 510(K)
- K910371URODYNAMIC MEASURING SYSTEM2Cleared 510(K)
- K910285BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP2Cleared 510(K)
- K910217MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM2Cleared 510(K)
- K904646BCI-100 FECAL INCONTINENCE SYSTEM2Cleared 510(K)
- K904386UROLAB JANUS2Cleared 510(K)
- K901494ETUDE, URODYNAMIC INVESTIGATION SYSTEM2Cleared 510(K)
- K902843BIOSEARCH ANAL BIOFEEDBACK DEVICE2Cleared 510(K)
- K902692DIAGNOSTIC ULTRASOUND/URO-GYN UDS 10022Cleared 510(K)
- K900494SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM2Cleared 510(K)
- K896575DANTEC MENUET2Cleared 510(K)
- K884920RECTUM-COLON MOTILITY MONITOR2Cleared 510(K)
- K884915DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER2Cleared 510(K)
- K881736SURGITEK CO2 DELIVERY SYSTEM2Cleared 510(K)
- K87475913L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE2Cleared 510(K)
- K874758DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE2Cleared 510(K)
- K870855UROSCAN2Cleared 510(K)
- K863312SANDHILL AMS2Cleared 510(K)
- K863165MODEL 4-SC FOUR WAY STOPCOCK2Cleared 510(K)
- K863168MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD2Cleared 510(K)
- K863167MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR2Cleared 510(K)
- K863169MODEL AS-72 ADMINISTRATION SET2Cleared 510(K)
- K862327MODEL RCV REFLUX CHECK VALVE2Cleared 510(K)
- K860571F.M. WEIST,KG (URODYNAMIC SYSTEMS)2Cleared 510(K)
- K853683UMS-1002Cleared 510(K)
- K853059LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE2Cleared 510(K)
- K8539361351 UROFLOW AUTO START2Cleared 510(K)
- K852856LABORIE URODYNAMICS PROCESSOR2Cleared 510(K)
- K851483UROBEI STRESS INCONTINENCE MONITOR2Cleared 510(K)
- K850694WSP CODE 4310 STRESSCATH2Cleared 510(K)
- K850696WSP CODE 4300 DIOMASTER DIAGNOSTIC2Cleared 510(K)
- K850695WSP CODE 4301 DIOMASTER THERAPEUTIC2Cleared 510(K)
- K850693WSP CODE 4315 PADTEST2Cleared 510(K)
- K8506021870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE2Cleared 510(K)
- K850601MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR2Cleared 510(K)
- K844503UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK2Cleared 510(K)
- K842124EMG MODULE, EMG1, W/OPTIONAL SPEAKER2Cleared 510(K)
- K834503PROFILE URODYNAMIC MONITORING SYS2Cleared 510(K)
- K833628LUMEN-4 URODYNAMIC CATHETER2Cleared 510(K)
- K823561URETHRAL PRESSURE PROFILE & TEMP. MODUL2Cleared 510(K)
- K822916UROCOMP REMOTE CONTROL 18042Cleared 510(K)
- K8234321512M/F WIRE ELECTRODE NEEDLE SET2Cleared 510(K)
- K821939UROCOMP MODEL 14042Cleared 510(K)
- K820144DISA WATER CYSTOMETER2Cleared 510(K)
- K812178LIFE-TECH #'S 1106/1156 UROLABS2Cleared 510(K)
- K802374ROBERTSON OBTURATION MONITOR INSUFFLA2Cleared 510(K)
- K800822CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE2Cleared 510(K)
- K792093BROWNE MODEL GD-52Cleared 510(K)
- K792094BROWNE MODEL UA-62Cleared 510(K)
- K792092BROWNE MODEL UD-4E2Cleared 510(K)
- K792091BROWNE MODEL UD-4D2Cleared 510(K)
- K792090BROWNE MODEL UD-42Cleared 510(K)
- K790754BROWNE MODEL CF-1 AND CF-1G2Cleared 510(K)
- K790478BROWNE MODEL UD-4DE2Cleared 510(K)
- K790519ULTRALITE UROSYSTEM, MODELS GU-1 & GU-22Cleared 510(K)
- K771850UROFLOW-CYSTOMETER SYSTEM2Cleared 510(K)
- K770579CATHETER, URETHRAL PRESSURE, UPE-10 & 122Cleared 510(K)
- 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
- 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
- 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
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K790519
- 510(k) Type
- Traditional
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/14/1979
- Days to Decision
- 59 days