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
- K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI Models2Cleared 510(K)
- K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)2Cleared 510(K)
- K231254GripTract-GI Endoscopic Tissue Manipulator2Cleared 510(K)
- K232922Pure-Vu EVS System2Cleared 510(K)
- K230332Ambu® aScope™ Colon; Ambu® aBox™ 22Cleared 510(K)
- K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM012Cleared 510(K)
- K230588Aer-O-Scope Colonoscope System2Cleared 510(K)
- K221452DiLumen C1, EZ1 and Tool Mount2Cleared 510(K)
- K213773Insufflation Retention Device2Cleared 510(K)
- K220158G-EYE System2Cleared 510(K)
- K213578Balloon Dilatation Catheter2Cleared 510(K)
- K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))2Cleared 510(K)
- K220007Pure-Vu EVS System2Cleared 510(K)
- K211819DiLumen C2 and Tool Mount2Cleared 510(K)
- K210981Pure Vu System2Cleared 510(K)
- K210851DiLumen Endolumenal Interventional Platform (DiLumen)2Cleared 510(K)
- K202469G-EYE System2Cleared 510(K)
- K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I2Cleared 510(K)
- K192588G-EYE System2Cleared 510(K)
- K190669Endotics2Cleared 510(K)
- K192664FUJIFILM Endoscope Model EC-760Z-V/L2Cleared 510(K)
- K191220Pure Vu System2Cleared 510(K)
- K190649FUJIFILM Endoscope Model EC-760S-V/L2Cleared 510(K)
- K181084PENTAX Video Colonoscopes (EC Family)2Cleared 510(K)
- K182540DiLumen Endolumenal Interventional Platform2Cleared 510(K)
- K180285PENTAX Medical Video Colonoscope EC34-i10T Series2Cleared 510(K)
- K181437Pure Vu System2Cleared 510(K)
- K173317DiLumen C2; DiLumen Tool Mount2Cleared 510(K)
- K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS2Cleared 510(K)
- K171673Focus Cap2Cleared 510(K)
- K173085invendoscopy E210 System2Cleared 510(K)
- K173392Pure-Vu System2Cleared 510(K)
- K172036Medrobotics Flex Robotic System2Cleared 510(K)
- K162330Flex Robotic System and Flex Colorectal Drive2Cleared 510(K)
- K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear2Cleared 510(K)
- K162428DiLumen Endolumenal Interventional Platform2Cleared 510(K)
- K162622Fujifilm Endoscope Models EC-600HL and EC-600LS2Cleared 510(K)
- K160015Pure Vu2Cleared 510(K)
- K161355invendoscopy E200 System2Cleared 510(K)
- K161791Aer-O-Scope Colonoscope System2Cleared 510(K)
- K160356Third Eye Panoramic Auxiliary Endoscopy System - Resposable2Cleared 510(K)
- K160196Fujifilm Video Colonoscope Model EC-600WL V22Cleared 510(K)
- K153483Balloon controller PB-302Cleared 510(K)
- K143732FUJIFILM Endoscope Models EC-600HL and EC-600LS2Cleared 510(K)
- K140595THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM2Cleared 510(K)
- K141598FUSE COLONOSCOPY SYSTEM2Cleared 510(K)
- K141286AER-O-SCOPE COLONOSCOPE SYSTEM2Cleared 510(K)
- K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)2Cleared 510(K)
- K132839FUSE 1C COLONOSCOPY SYSTEM2Cleared 510(K)
- K132210FUJIFILM 600 SERIES ENDOSCOPES2Cleared 510(K)
- K131780EVIS EXERA III VIDEO SYSTEM2Cleared 510(K)
- K130718PEERSCOPE SYSTEM2Cleared 510(K)
- K121582INVENDO C25 COLONOSCOPY SYSTEM2Cleared 510(K)
- K120289PEERSCOPE SYSTEM2Cleared 510(K)
- K112391FUJINON COLONOSCOPES2Cleared 510(K)
- K113050CLEARPATH LOWER GI2Cleared 510(K)
- K111756V1 SYSTEM2Cleared 510(K)
- K100624INVENDO C20 COLONOSCOPY SYSTEM2Cleared 510(K)
- K112680EVIS EXERA III VIDEO SYSTEM2Cleared 510(K)
- K111028EUS BALLOON2Cleared 510(K)
- K103312UPD-Y00032Cleared 510(K)
- K102616NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE2Cleared 510(K)
- K100966COLONOSCOPE/SIGMOIDOSCOPE SHEATHES2Cleared 510(K)
- K101191NAVIAID ICVI DEVICE2Cleared 510(K)
- K101053OLYMPUS CF TYPE Y0023-L, Y0023I2Cleared 510(K)
- K093037PENTEX EC-3890LI2Cleared 510(K)
- K093187MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM2Cleared 510(K)
- K091305CLEARPATH2Cleared 510(K)
- K091783THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM2Cleared 510(K)
- K090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B152Cleared 510(K)
- K083180THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM2Cleared 510(K)
- K081004PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL2Cleared 510(K)
- K080317ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL2Cleared 510(K)
- K070622NEOGUIDE ENDOSCOPY SYSTEM2Cleared 510(K)
- K070330THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM2Cleared 510(K)
- K063654ENDOGUIDE2Cleared 510(K)
- K063585KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM2Cleared 510(K)
- K052930NAVIGATOR ENDOSCOPY SYSTEM2Cleared 510(K)
- K051068ZUTRON COLONOSCOPE STIFFENING DEVICE2Cleared 510(K)
- K051541GF-UE160-AL5 ULTRASOUND ENDOSCOPE2Cleared 510(K)
- K043487EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/12Cleared 510(K)
- K041903FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL52Cleared 510(K)
- K032688COLONOSIGHT MODEL 510B2Cleared 510(K)
- K023259INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS12002Cleared 510(K)
- K002749ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D2Cleared 510(K)
- K001241EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I2Cleared 510(K)
- K970372GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS2Cleared 510(K)
- K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)2Cleared 510(K)
- K961563EC-384OTL, VIDEO COLONSCOPE2Cleared 510(K)
- K951574EC-3800L, VIDEO COLONOSCOPE2Cleared 510(K)
- K951579EC-3800TL, VIDEO COLONOSCOPE2Cleared 510(K)
- K954704VS-200 VIDEO SIGMOIDOSCOPE2Cleared 510(K)
- K951575FC-38TLH, FIBER COLONOSCOPE2Cleared 510(K)
- K951580FC-38LH, FIBER COLONOSCCOPE2Cleared 510(K)
- K951578FC-38LX, FIBER COLONOSCOPE2Cleared 510(K)
- K943895VISION SYSTEM COLONSCOPE2Cleared 510(K)
- K901610SULLIVAN VARIABLE STIFFNESS CABLE2Cleared 510(K)
- K884857COLONOSCOPE GUIDING TUBE DEVICE2Cleared 510(K)
- K822846PENTAX FC-38LA & FC-38SA COLONOFIBER2Cleared 510(K)
- K810682PENTAX COLONOSCOPE MODEL FC-34LA2Cleared 510(K)
- K810791PENTAX COLONOSCOPE MODEL FC-34 MA2Cleared 510(K)
- K810654STOPPERLESS HOT/COLD RUBBER WATER BOTTLE2Cleared 510(K)
- K801223PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A2Cleared 510(K)
- K792179AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE2Cleared 510(K)
- K790338COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER2Cleared 510(K)
- K760452COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)2Cleared 510(K)
- 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
Balloon Dilatation Catheter
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213578
- 510(k) Type
- Traditional
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/6/2022
- Days to Decision
- 147 days
- Submission Type
- Summary