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
- 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
Esophageal, Mucosal, Electrical Characterization
- Page Type
- Product Code
- Definition
- The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
- Physical State
- The device consists of a probe, cables, and other processing equipment to record and display the electrical characteristics of the esophageal tissue.
- Technical Method
- The device goes into the esophagus and comes in contact with the tissue. Through sensors or other means, the electrical characterization of the tissue is recorded and later displayed.
- Target Area
- Esophagus
- Regulation Medical Specialty
- Gastroenterology and Urology
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 876.1450
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 876.1450 Esophageal tissue characterization system
§ 876.1450 Esophageal tissue characterization system.
(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) All patient contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.
(6) Performance data must validate the reprocessing instructions for any reusable components of the device.
(7) Labeling must include:
(i) Specific instructions regarding the proper placement and use of the device;
(ii) Instructions for reprocessing of any reusable components; and
(iii) An expiration date for single use components.
[86 FR 68399, Dec. 2, 2021]