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
- K241842Luer-Split MAJ-20922Cleared 510(K)
- K250140Defendo Fujifilm 700 Single Use Cleaning Adapter2Cleared 510(K)
- K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)2Cleared 510(K)
- K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)2Cleared 510(K)
- K241285Disposable Endoscope Valves Set (AF series)2Cleared 510(K)
- K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector2Cleared 510(K)
- K232327Endorail2Cleared 510(K)
- K240352Defendo Single Use Cleaning Adapter for Olympus Endoscopes2Cleared 510(K)
- K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector2Cleared 510(K)
- K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)2Cleared 510(K)
- K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter2Cleared 510(K)
- K232249PENTAX Medical Gas/Water Feeding Valve OE-B142Cleared 510(K)
- K232244Disposable Endoscope Valves System2Cleared 510(K)
- K222499Disposable Endoscope Valves Kit2Cleared 510(K)
- K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)2Cleared 510(K)
- K232118ANDORATE® Valve Kit2Cleared 510(K)
- K220884Disposable Endoscope Valve Sets2Cleared 510(K)
- K222980Pentax Medical Valve Set2Cleared 510(K)
- K221331Disposable Endoscope Valves System2Cleared 510(K)
- K220210Disposable Endoscopy Adapter Set2Cleared 510(K)
- K221264FROG Forceps Valve (VAL1-F1-100)2Cleared 510(K)
- K213483SnapLoc Wire Lock2Cleared 510(K)
- K220247Guidewire Locking Device2Cleared 510(K)
- K211814Wellead Endoscopic Seal2Cleared 510(K)
- K213095andorate Suction Valve, andorate Air/Water Valve2Cleared 510(K)
- K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve2Cleared 510(K)
- K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor2Cleared 510(K)
- K210353AutoCap RX2Cleared 510(K)
- K202104BioGuard EUS Air/Water and Suction Valves2Cleared 510(K)
- K203630BioGuard Air/Water and Suction Valves2Cleared 510(K)
- K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B2Cleared 510(K)
- K202237Locking device2Cleared 510(K)
- K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve2Cleared 510(K)
- K200481Andorate Biopsy Valve, Andorate Biopsy Irrigator2Cleared 510(K)
- K192048Single Use Endoscope Valves Set2Cleared 510(K)
- K192258Disposable Valve Sets2Cleared 510(K)
- K192059Bio Guard Air/Water & Suction Valves2Cleared 510(K)
- K191231Andorate Auxiliary Water Connector, Andorate Valves Set2Cleared 510(K)
- K190164CleverLock Guidewire Locking Device and Biopsy Cap2Cleared 510(K)
- K181712San Antonio Stopcock2Cleared 510(K)
- K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter2Cleared 510(K)
- K162142Accessory Irrigation Adapter2Cleared 510(K)
- K160403SmartStart Air/Water and Suction Valves2Cleared 510(K)
- K151714Disposable Endoscope Valves Set A2Cleared 510(K)
- K151345BioGuard Air/Water Valve, BioGuard Suction Valve2Cleared 510(K)
- K112698CONCENTRIC BALLOON GOOGLE2Cleared 510(K)
- K112106NAVIAID ICVI-F,S,B,R DEVICE2Cleared 510(K)
- K103155SUMO ACCESS AND TISSUE RESECTION SYSTEM2Cleared 510(K)
- K111760NAVIAID(TM) BGC DEVICE2Cleared 510(K)
- K110291NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE2Cleared 510(K)
- K110088DEFENDO Y-OPSY IRRIGATOR2Cleared 510(K)
- K102581DEFENDO DISPOSABLE SUCTION VALVE MODEL 1003052Cleared 510(K)
- K102409DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 1003042Cleared 510(K)
- K101094CLEARJET2Cleared 510(K)
- K093329SCOPE INTRODUCER MODEL 74002Cleared 510(K)
- K090851DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)2Cleared 510(K)
- K080764SUCCESS CECAL INTUBATION ASSIST, MODEL: 41002Cleared 510(K)
- K073484ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN04322Cleared 510(K)
- K073507ANCHORAGE ACCESS KIT2Cleared 510(K)
- K024301LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT2Cleared 510(K)
- K010610RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 45272Cleared 510(K)
- K970110BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)2Cleared 510(K)
- K920030SURESEAL ENDOSCOPIC VALVE2Cleared 510(K)
- K915719ANGEION ENDOSCOPIC VALVE SEAL2Cleared 510(K)
- K884097MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES2Cleared 510(K)
- K862107PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR2Cleared 510(K)
- K800962M.R. ASSOC. WASHING TUBE/MEASURING TUBE2Cleared 510(K)
- 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
Wellead Endoscopic Seal
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211814
- 510(k) Type
- Traditional
- Applicant
- Well Lead Medical CO., LTD.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/14/2022
- Days to Decision
- 217 days
- Submission Type
- Summary