Anesthesiology
Review Panel
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- 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
- K241704Endoscopic Water Pump2Cleared 510(K)
- K242357Water Container (MAJ-901); Water Container (MAJ-902)2Cleared 510(K)
- K241874Aspiration Catheter (2189)2Cleared 510(K)
- K242134ClearCap Distal Attachment2Cleared 510(K)
- K233442troCarWash™ System2Cleared 510(K)
- K230773Endoscopy Irrigation Tubing2Cleared 510(K)
- K231471Air/Water Bottle Tubing, CO2 Source Tubing2Cleared 510(K)
- K231418ENDOGATOR™ Hybrid Irrigation Tubing2Cleared 510(K)
- K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing2Cleared 510(K)
- K230932ANDORATE® Valve Kit2Cleared 510(K)
- K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)2Cleared 510(K)
- K222695troCarWash™ System2Cleared 510(K)
- K223171AquaPulse® Irrigation Tubing2Cleared 510(K)
- K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing2Cleared 510(K)
- K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing2Cleared 510(K)
- K220785Clean Connecting Tube2Cleared 510(K)
- K221824OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-3152Cleared 510(K)
- K221177Erbe's Tubing/Cap Sets2Cleared 510(K)
- K210618Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series2Cleared 510(K)
- K203350ENDOtube2Cleared 510(K)
- K202616ClearCap Distal Attachment2Cleared 510(K)
- K202560AquaPulse Irrigation Tubing2Cleared 510(K)
- K200479AquaPulse Auxiliary Water Connector2Cleared 510(K)
- K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector2Cleared 510(K)
- K193250Irrigation Tubing with CO2 or Air2Cleared 510(K)
- K193036C2 CryoBalloon EndoGrip2Cleared 510(K)
- K191366Vacutore Air/Water Bottle Tubing2Cleared 510(K)
- K181457EndoStream(TM)2Cleared 510(K)
- K181418ScopeFlow Pure(TM)2Cleared 510(K)
- K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector2Cleared 510(K)
- K190469ERBEFLO 2 Disposable Tubing System2Cleared 510(K)
- K182998Andorate Auxiliary Water Connector2Cleared 510(K)
- K182319Glo-Tip Spray Catheter2Cleared 510(K)
- K182444ERBEFLO Olympus Scope Port Connector2Cleared 510(K)
- K182275Seal Single Use Biopsy Valve2Cleared 510(K)
- K181509Endorate Valve Sets2Cleared 510(K)
- K173758Disposable Biopsy Valve2Cleared 510(K)
- K171637OpClear System2Cleared 510(K)
- K161167Seal Single-Use Biopsy Valve2Cleared 510(K)
- K152278ENDOFLOW II - Irrigation, Warming and Suction System2Cleared 510(K)
- K152140Boa Endoscopic Valve2Cleared 510(K)
- K142068BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE2Cleared 510(K)
- K143186Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector2Cleared 510(K)
- K140753ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM2Cleared 510(K)
- K140315US ENDOSCOPY DISTAL ATTACHMENT CAP2Cleared 510(K)
- K133734SEAL SINGLE-USE BIOPSY VALVE2Cleared 510(K)
- K140405TORRENT IRRIGATION SYSTEM2Cleared 510(K)
- K131426MEDLINE BIOPSY VALVE2Cleared 510(K)
- K132776SEAL BIOPSY VALVE - REUSABLE2Cleared 510(K)
- K122417SCOPEVALET DISPOSABLE BIOPSY VALVE2Cleared 510(K)
- K130909GATEWAY ADVANAGE Y-ADAPTER2Cleared 510(K)
- K122740JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN2Cleared 510(K)
- K112318CLEARPATH 242Cleared 510(K)
- K113119ENDOGATOR ADVANTAGE IRRIGATION PUMP2Cleared 510(K)
- K111274JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-1690382Cleared 510(K)
- K111821BIOPSY VALVE2Cleared 510(K)
- K103239IRRIGATION SYSTEM2Cleared 510(K)
- K103235ERBEFLO 2 DISPOSABLE TUBING SYSTEM2Cleared 510(K)
- K102855UNIVERSAL IRRIGATION SOLUTION HYBRID2Cleared 510(K)
- K092461IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 007111402Cleared 510(K)
- K060962ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-1002Cleared 510(K)
- K031457ENDOMAT LC PUMP, MODEL 20 3303 202Cleared 510(K)
- K033695IRRIGATION CHANNEL TUBING, MODEL 1001352Cleared 510(K)
- K031773ENDO GATOR SYSTEM2Cleared 510(K)
- K030765HOBBS MISTIFIER SPRAY CATHETER2Cleared 510(K)
- K021776KSEA QUADRO SWITCH2Cleared 510(K)
- K020614IRRIGATING CANNULA2Cleared 510(K)
- K993778HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-002Cleared 510(K)
- K992535ENDIUS SUCTION/IRRIGATION INSTRUMENT2Cleared 510(K)
- K971125ENDO SMARTCAP (100501)2Cleared 510(K)
- K970764COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES2Cleared 510(K)
- K964196CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)2Cleared 510(K)
- K953655J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS2Cleared 510(K)
- K942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER2Cleared 510(K)
- K934170ENDOMEDIX Y-ADAPTER2Cleared 510(K)
- K931201TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER2Cleared 510(K)
- K905102BARD(R) SYRINGE ASSIST IRRIGATION2Cleared 510(K)
- K903834N. M. BEALE COMPANY VU-THRU WATER BOTTLE2Cleared 510(K)
- K892426NO. 86500 - ENDOSCOPIC JET WASHER2Cleared 510(K)
- K891339IRRI-FLO IRRIGATION DELIVERY SYSTEM2Cleared 510(K)
- K883173MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION2Cleared 510(K)
- K875264WASHING CATHETER2Cleared 510(K)
- K862058RAPID ENDOSCOPIC LAVAGE SYSTEM2Cleared 510(K)
- K844550HOBBS MEDICAL/JAYCO ASPIRATION CATHETER2Cleared 510(K)
- K844691ENDOSCOPIC ASPIRATION CATHETER SET2Cleared 510(K)
- K833331ASPIRATION & IRRIGATION CATHETER2Cleared 510(K)
- K832009MODEL #27224P CONTINUOUS FLOW PUMP2Cleared 510(K)
- K822061LAVAGING CATHETERS2Cleared 510(K)
- K810506PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT2Cleared 510(K)
- K760451AIR WATER SOURCE (ACMI MODEL 710)2Cleared 510(K)
- 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
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
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C2 CryoBalloon EndoGrip
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K193036
- 510(k) Type
- Special
- Applicant
- PENTAX Medical, A Division of PENTAX of America, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/22/2019
- Days to Decision
- 22 days
- Submission Type
- Summary