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
- K242779Hood (DH-083ST)2Cleared 510(K)
- K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP2Cleared 510(K)
- K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH1902Cleared 510(K)
- K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 22Cleared 510(K)
- K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)2Cleared 510(K)
- K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)2Cleared 510(K)
- K221551FUJIFILM Endoscope Model EI-740D/S2Cleared 510(K)
- K213606EvoEndo Single-Use Endoscopy System2Cleared 510(K)
- K212382Ambu® aScope™ Gastro, Ambu® aBox™22Cleared 510(K)
- K210177PENTAX Medical Video Upper GI Scopes EG17-J102Cleared 510(K)
- K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN22Cleared 510(K)
- K210915Pathfinder Endoscope Cap2Cleared 510(K)
- K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)2Cleared 510(K)
- K210162Endoscope Model EI-740D/S2Cleared 510(K)
- K192704Endofresh Digestive Endoscopy System2Cleared 510(K)
- K200850Fujifilm Ultrasonic Processor2Cleared 510(K)
- K193123FUJIFILM Distal Cap Models 33-402Cleared 510(K)
- K190799PENTAX Medical Video Upper GI Scopes (EG Family)2Cleared 510(K)
- K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L2Cleared 510(K)
- K182836FUJIFILM Endoscope Model EG-740N2Cleared 510(K)
- K183686FUJIFILM Endoscope Model EG-530N2Cleared 510(K)
- K180292PENTAX Video Upper G.I. Scope EG34-i102Cleared 510(K)
- K180341FUJIFILM 600 Series Endoscope EG-600WR v22Cleared 510(K)
- K181763FUJIFILM Ultrasonic Endoscope2Cleared 510(K)
- K180911Visura Technologies TEECAD System2Cleared 510(K)
- K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type2Cleared 510(K)
- K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-6032Cleared 510(K)
- K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR2Cleared 510(K)
- K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-12Cleared 510(K)
- K152182Fuse Gastroscopy System2Cleared 510(K)
- K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes2Cleared 510(K)
- K140295GIS ENDOSCOPIC OPTICAL LENS2Cleared 510(K)
- K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)2Cleared 510(K)
- K131422PEERSCOPE SYSTEM2Cleared 510(K)
- K130148FOREIGN BODY HOOD2Cleared 510(K)
- K123317EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N2Cleared 510(K)
- K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT22Cleared 510(K)
- K113166CLEARPATH UPPER GI2Cleared 510(K)
- K111243FUJINON ULTRASONIC PROCESSOR2Cleared 510(K)
- K093779CLEARPATH UGI2Cleared 510(K)
- K063316FUJINON MODEL EG-530N TRANS NASAL INSERTION2Cleared 510(K)
- K063847FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-7002Cleared 510(K)
- K060907KARL STORZ VIDEO GASTROSCOPES2Cleared 510(K)
- K042043FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR52Cleared 510(K)
- K032177GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I2Cleared 510(K)
- K021886OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P2Cleared 510(K)
- K013640EG-3630UR, ULTRASUND VIDEO GASTROSCOPE2Cleared 510(K)
- K011151EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z2Cleared 510(K)
- K002231LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K001766OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE2Cleared 510(K)
- K984358OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-5972Cleared 510(K)
- K974493FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES2Cleared 510(K)
- K971734VG 200 VIDEO GASTROSCOPE2Cleared 510(K)
- K971660OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K963023ULTRASOUND GASTROSCOPE GF TYPE UM30P2Cleared 510(K)
- K962897EG-3400, VIDEO GASTROSCOPE2Cleared 510(K)
- K962460EG-3800T, VIDEO GASTROSCOPE2Cleared 510(K)
- K961564EG-2940, VIDEO GASTROSCOPE2Cleared 510(K)
- K943715VISION SYSTEM UPPER G.I. EXDOSCOPE2Cleared 510(K)
- K933717OLYMPUS MEASURING DEVICES2Cleared 510(K)
- K850020PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-232Cleared 510(K)
- K833924TWO CHANNEL GASTROFIBERSCOPE FG-36T2Cleared 510(K)
- K832007PENTAX FG-34JA GASTROFIBERSCOPE2Cleared 510(K)
- 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
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K210485
- 510(k) Type
- Traditional
- Applicant
- PENTAX of America, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/13/2021
- Days to Decision
- 83 days
- Submission Type
- Summary