FDS
EvoEndo Single-Use Endoscopy System
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 74
Adverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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 FDS
- K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- K251708 — EvoEndo Single-Use Endoscopy System
- K243388 — Disposable Distal Cap
- K250900 — EvoEndo Single-Use Endoscopy System
- K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- K242635 — Endoscopic Distal Attachment (AF-D series)
- K250296 — Disposable Distal Attachment D-201 Series
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K242779 — Hood (DH-083ST)
- K240142 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
- K232919 — Ambu® aScope Gastro Large; Ambu® aBox 2
- K232028 — Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
- K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
- K221551 — FUJIFILM Endoscope Model EI-740D/S
- K213606 — EvoEndo Single-Use Endoscopy System
- K212382 — Ambu® aScope Gastro, Ambu® aBox2
- K210177 — PENTAX Medical Video Upper GI Scopes EG17-J10
- K212296 — Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
- K210915 — Pathfinder Endoscope Cap
- K210485 — PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
- K210162 — Endoscope Model EI-740D/S
- K192704 — Endofresh Digestive Endoscopy System
- K200850 — Fujifilm Ultrasonic Processor
- K193123 — FUJIFILM Distal Cap Models 33-40
- K190799 — PENTAX Medical Video Upper GI Scopes (EG Family)
- K183572 — FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
- K182836 — FUJIFILM Endoscope Model EG-740N
- K183686 — FUJIFILM Endoscope Model EG-530N
- K180292 — PENTAX Video Upper G.I. Scope EG34-i10
- K180341 — FUJIFILM 600 Series Endoscope EG-600WR v2
- K181763 — FUJIFILM Ultrasonic Endoscope
- K180911 — Visura Technologies TEECAD System
- K173004 — SB Soft Hood - Straight type, SB Soft Hood - Undercut type
- K172916 — FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
- K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
- K153206 — Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
- K152182 — Fuse Gastroscopy System
- K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
- K140295 — GIS ENDOSCOPIC OPTICAL LENS
- K131902 — PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
- K131422 — PEERSCOPE SYSTEM
- K130148 — FOREIGN BODY HOOD
- K123317 — EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
- K120446 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
- K113166 — CLEARPATH UPPER GI
- K111243 — FUJINON ULTRASONIC PROCESSOR
- K093779 — CLEARPATH UGI
- K063316 — FUJINON MODEL EG-530N TRANS NASAL INSERTION
- K063847 — FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
- K060907 — KARL STORZ VIDEO GASTROSCOPES
- K042043 — FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
- K032177 — GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
- K021886 — OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
- K013640 — EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
- K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
- K002231 — LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT
- K001766 — OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
- K984358 — OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
- K974493 — FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
- K971734 — VG 200 VIDEO GASTROSCOPE
- K971660 — OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
- K963023 — ULTRASOUND GASTROSCOPE GF TYPE UM30P
- K962897 — EG-3400, VIDEO GASTROSCOPE
- K962460 — EG-3800T, VIDEO GASTROSCOPE
- K961564 — EG-2940, VIDEO GASTROSCOPE
- K943715 — VISION SYSTEM UPPER G.I. EXDOSCOPE
- K933717 — OLYMPUS MEASURING DEVICES
- K850020 — PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
- K833924 — TWO CHANNEL GASTROFIBERSCOPE FG-36T
- K832007 — PENTAX FG-34JA GASTROFIBERSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.