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
- K240007Solar Compact (G4-1)2Cleared 510(K)
- K231861EndoflipTM 300 System2Cleared 510(K)
- K223705EndoflipTM 3002Cleared 510(K)
- K222000Transit-Pellets2Cleared 510(K)
- K201106IntraMarX 3D Radiopaque Marker2Cleared 510(K)
- K191087IntraMarX Radiopaque Markers2Cleared 510(K)
- K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe2Cleared 510(K)
- K181760Transit-Pellets2Cleared 510(K)
- K183072EndoFLIP System2Cleared 510(K)
- K181750SITZMARKS2Cleared 510(K)
- K170833EndoFLIP® System with FLIP Topography module2Cleared 510(K)
- K160287Rapid Barostat Bag (RBB) Pump and Catheter2Cleared 510(K)
- K160170Lehman Manometry Catheter2Cleared 510(K)
- K160725EndoFLIP2Cleared 510(K)
- K151086ManoScan System2Cleared 510(K)
- K130906ENDOFLIP CATHETER2Cleared 510(K)
- K122294PRESSURIZED INFUSION PUMP2Cleared 510(K)
- K120997BAROSTAT SOFTWARE OPTION2Cleared 510(K)
- K121014SOLAR GI2Cleared 510(K)
- K120524SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM2Cleared 510(K)
- K102214ENDO FLIP2Cleared 510(K)
- K102801PHTIP DISPOSABLE ISFET CATHETER2Cleared 510(K)
- K092850ENDOFLIP2Cleared 510(K)
- K091070MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM2Cleared 510(K)
- K082056ANORECTAL MANOMETRY SOFTWARE OPTION ARM-12Cleared 510(K)
- K071094MODIFICATION TO SOLAR GI2Cleared 510(K)
- K062222UNITIP HIGH RESOLUTION CATHETER2Cleared 510(K)
- K060166OHMEGA2Cleared 510(K)
- K052338SOLAR GI2Cleared 510(K)
- K031084SOLAR GI SYSTEM2Cleared 510(K)
- K031169MOTILITY VISUALIZATION SYSTEM2Cleared 510(K)
- K011471BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER2Cleared 510(K)
- K012232INSIGHT, MODEL S9800002Cleared 510(K)
- K013154MARK II/MARK III MANOMETRIC PERFUSION PUMP2Cleared 510(K)
- K011472POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID2Cleared 510(K)
- K003580UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER2Cleared 510(K)
- K002427SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-00262Cleared 510(K)
- K004040REDTECH GIPC 20002Cleared 510(K)
- K010130POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S01032Cleared 510(K)
- K000386POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S01112Cleared 510(K)
- K992713POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S01012Cleared 510(K)
- K991389ANORECTAL MANOMETRY SUITE, MODEL 9032S02012Cleared 510(K)
- K991288DISTENDER SERIES II BAROSTAT2Cleared 510(K)
- K973844GASTRIC AND RECTAL CATHETERS2Cleared 510(K)
- K990441INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S9813002Cleared 510(K)
- K981733DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S01112Cleared 510(K)
- K984444INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S9800002Cleared 510(K)
- K980980MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P502Cleared 510(K)
- K980946MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP2Cleared 510(K)
- K972439ANORECTAL MANOMETRY ANALYSIS MODULE2Cleared 510(K)
- K963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM2Cleared 510(K)
- K942247SMALL BOWEL ANALYSIS SOFTWARE2Cleared 510(K)
- K921682ZINETICS AMC2Cleared 510(K)
- K932306MICROINFUSOR2Cleared 510(K)
- K920664DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION2Cleared 510(K)
- K921062GAELTEC MPR SERIES2Cleared 510(K)
- K905154GASTROSCAN2Cleared 510(K)
- K900058WILSON-COOK BILIARY MOTILITY CATHETER2Cleared 510(K)
- K880581AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.2Cleared 510(K)
- K881609SITZMARKS2Cleared 510(K)
- K874690GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER2Cleared 510(K)
- K832869MOTILITY MEASUREMENT SYS MMS-1002Cleared 510(K)
- K831347MICROCAPILLARY INFUSION SYSTEM2Cleared 510(K)
- K830421SYN-02 PN AMPLIFIER2Cleared 510(K)
- K823701MOTILITY CATHETERS2Cleared 510(K)
- K812103ESOPHAGEAL MOTILITY APPARATUS2Cleared 510(K)
- K780812ESOPHAGEAL MOTILITY SYSTEM - MODEL 33302Cleared 510(K)
- K760761ESOPHAGEAL MOTILITY TUBE2Cleared 510(K)
- 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
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K120524
- 510(k) Type
- Traditional
- Applicant
- MUI SCIENTIFIC
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/21/2012
- Days to Decision
- 120 days
- Submission Type
- Summary