FDF
G-EYE System
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 111
Adverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FDF
1–100 of 111- K252457 — Disposable Distal End Tape Hood
- K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
- K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
- K232043 — Endoscopic 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)
- K231254 — GripTract-GI Endoscopic Tissue Manipulator
- K232922 — Pure-Vu EVS System
- K230332 — Ambu® aScope Colon; Ambu® aBox 2
- K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
- K230588 — Aer-O-Scope Colonoscope System
- K221452 — DiLumen C1, EZ1 and Tool Mount
- K213773 — Insufflation Retention Device
- K220158 — G-EYE System
- K213578 — Balloon Dilatation Catheter
- K210052 — Saneso 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))
- K220007 — Pure-Vu EVS System
- K211819 — DiLumen C2 and Tool Mount
- K210981 — Pure Vu System
- K210851 — DiLumen Endolumenal Interventional Platform (DiLumen)
- K202469 — G-EYE System
- K192793 — Evis 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-HQ190I
- K192588 — G-EYE System
- K190669 — Endotics
- K192664 — FUJIFILM Endoscope Model EC-760Z-V/L
- K191220 — Pure Vu System
- K190649 — FUJIFILM Endoscope Model EC-760S-V/L
- K181084 — PENTAX Video Colonoscopes (EC Family)
- K182540 — DiLumen Endolumenal Interventional Platform
- K180285 — PENTAX Medical Video Colonoscope EC34-i10T Series
- K181437 — Pure Vu System
- K173317 — DiLumen C2; DiLumen Tool Mount
- K180405 — FUJIFILM Endoscope Models EC-600HL and EC-600LS
- K171673 — Focus Cap
- K173085 — invendoscopy E210 System
- K173392 — Pure-Vu System
- K172036 — Medrobotics Flex Robotic System
- K162330 — Flex Robotic System and Flex Colorectal Drive
- K163492 — Oracle 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 Linear
- K162428 — DiLumen Endolumenal Interventional Platform
- K162622 — Fujifilm Endoscope Models EC-600HL and EC-600LS
- K160015 — Pure Vu
- K161355 — invendoscopy E200 System
- K161791 — Aer-O-Scope Colonoscope System
- K160356 — Third Eye Panoramic Auxiliary Endoscopy System - Resposable
- K160196 — Fujifilm Video Colonoscope Model EC-600WL V2
- K153483 — Balloon controller PB-30
- K143732 — FUJIFILM Endoscope Models EC-600HL and EC-600LS
- K140595 — THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
- K141286 — AER-O-SCOPE COLONOSCOPE SYSTEM
- K141598 — FUSE COLONOSCOPY SYSTEM
- K131855 — PENTAX VIDEO COLONOSCOPES (EC FAMILY)
- K132839 — FUSE 1C COLONOSCOPY SYSTEM
- K132210 — FUJIFILM 600 SERIES ENDOSCOPES
- K131780 — EVIS EXERA III VIDEO SYSTEM
- K130718 — PEERSCOPE SYSTEM
- K121582 — INVENDO C25 COLONOSCOPY SYSTEM
- K120289 — PEERSCOPE SYSTEM
- K112391 — FUJINON COLONOSCOPES
- K113050 — CLEARPATH LOWER GI
- K111756 — V1 SYSTEM
- K100624 — INVENDO C20 COLONOSCOPY SYSTEM
- K112680 — EVIS EXERA III VIDEO SYSTEM
- K111028 — EUS BALLOON
- K103312 — UPD-Y0003
- K102616 — NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
- K100966 — COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
- K101191 — NAVIAID ICVI DEVICE
- K101053 — OLYMPUS CF TYPE Y0023-L, Y0023I
- K093037 — PENTEX EC-3890LI
- K093187 — MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K091305 — CLEARPATH
- K091783 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
- K090116 — FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
- K083180 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K081004 — PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
- K080317 — ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
- K070622 — NEOGUIDE ENDOSCOPY SYSTEM
- K070330 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K063585 — KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
- K063654 — ENDOGUIDE
- K052930 — NAVIGATOR ENDOSCOPY SYSTEM
- K051068 — ZUTRON COLONOSCOPE STIFFENING DEVICE
- K051541 — GF-UE160-AL5 ULTRASOUND ENDOSCOPE
- K043487 — EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
- K041903 — FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
- K032688 — COLONOSIGHT MODEL 510B
- K023259 — INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
- K002749 — ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
- K001241 — EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
- K970372 — GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
- K961570 — KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
- K961563 — EC-384OTL, VIDEO COLONSCOPE
- K951574 — EC-3800L, VIDEO COLONOSCOPE
- K951579 — EC-3800TL, VIDEO COLONOSCOPE
- K954704 — VS-200 VIDEO SIGMOIDOSCOPE
- K951575 — FC-38TLH, FIBER COLONOSCOPE
- K951578 — FC-38LX, FIBER COLONOSCOPE
- K951580 — FC-38LH, FIBER COLONOSCCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.