510(k) clearances for Gastroscope And Accessories, Flexible/rigid
76 on file
- Intuitive Surgical, Inc.Aug 7, 2026
K253702 · Intuitive Endoluminal Gastrointestinal System (IG1000)
- EvoEndo, Inc.Apr 21, 2026
K260573 · EvoEndo Single-Use Endoscopy System
- Fujifilm CorporationFeb 17, 2026
K250550 · FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- Fujifilm CorporationFeb 6, 2026
K253568 · Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
- Pentax of America, Inc.Dec 16, 2025
K251256 · PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- Actuated Medical, Inc.Oct 31, 2025
K251041 · GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- EvoEndo, Inc.Oct 10, 2025
K251708 · EvoEndo Single-Use Endoscopy System
- Micro-Tech (Nanjing) Co., Ltd.Jun 27, 2025
K243388 · Disposable Distal Cap
- EvoEndo, Inc.Jun 16, 2025
K250900 · EvoEndo Single-Use Endoscopy System
- Fujifilm CorporationJun 10, 2025
K243512 · FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- Alton (Shanghai) Medical Instruments Co., Ltd.May 30, 2025
K242635 · Endoscopic Distal Attachment (AF-D series)
- Olympus Medical Systems Corp.May 1, 2025
K250296 · Disposable Distal Attachment D-201 Series
- Pentax of America, Inc.Dec 6, 2024
K241213 · PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- Fujifilm CorporationOct 11, 2024
K242779 · Hood (DH-083ST)
- Fujifilm CorporationSep 4, 2024
K240142 · FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- Olympus Medical Systems CorporationJun 19, 2024
K232997 · EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
- Ambu A/SApr 5, 2024
K232919 · Ambu® aScope Gastro Large; Ambu® aBox 2
- Iq Endoscopes LimitedNov 17, 2023
K232028 · Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
- FUJIFILM Healthcare Americas CorporationSep 1, 2023
K232314 · Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
- Fujifilm CorporatonJan 27, 2023
K221551 · FUJIFILM Endoscope Model EI-740D/S
- EvoEndo, Inc.Feb 14, 2022
K213606 · EvoEndo Single-Use Endoscopy System
- Ambu A/SFeb 3, 2022
K212382 · Ambu® aScope Gastro, Ambu® aBox2
- Pentax of America, Inc.Oct 20, 2021
K210177 · PENTAX Medical Video Upper GI Scopes EG17-J10
- Fujifilm CorporationAug 19, 2021
K212296 · Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
- Neptune Medical, Inc.May 25, 2021
K210915 · Pathfinder Endoscope Cap
- Pentax of America, Inc.May 13, 2021
K210485 · PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
- Fujifilm CorporationApr 9, 2021
K210162 · Endoscope Model EI-740D/S
- Huizhou Xzing Technology Co., Ltd.Sep 2, 2020
K192704 · Endofresh Digestive Endoscopy System
- Fujifilm CorporationJul 6, 2020
K200850 · Fujifilm Ultrasonic Processor
- Fujifilm CorporationDec 11, 2019
K193123 · FUJIFILM Distal Cap Models 33-40
- Pentax of America, Inc.Nov 12, 2019
K190799 · PENTAX Medical Video Upper GI Scopes (EG Family)
- Fujifilm CorporationJul 16, 2019
K183572 · FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
- Fujifilm CorporationApr 2, 2019
K182836 · FUJIFILM Endoscope Model EG-740N
- Fujifilm CorporationFeb 28, 2019
K183686 · FUJIFILM Endoscope Model EG-530N
- Pentax Medical of America, Inc.Oct 12, 2018
K180292 · PENTAX Video Upper G.I. Scope EG34-i10
- Fujifilm CorporationAug 3, 2018
K180341 · FUJIFILM 600 Series Endoscope EG-600WR v2
- Fujifilm CorporationJul 27, 2018
K181763 · FUJIFILM Ultrasonic Endoscope
- Visura Technologies, LLCJun 20, 2018
K180911 · Visura Technologies TEECAD System
- Sumitomo Bakelite Co., Ltd.May 8, 2018
K173004 · SB Soft Hood - Straight type, SB Soft Hood - Undercut type
- Fujifilm CorporationMar 1, 2018
K172916 · FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
- Fujifilm Medical Systems U.S.A, Inc.Jun 15, 2017
K162749 · FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
- Fujifilm Medical System U.S.A., Inc.Mar 3, 2016
K153206 · Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
- Endochoice, Inc.Dec 10, 2015
K152182 · Fuse Gastroscopy System
- Fujifilm Medical System U.S.A., Inc.May 14, 2015
K142629 · EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
- Gi Scientific, LLCJul 24, 2014
K140295 · GIS ENDOSCOPIC OPTICAL LENS
- Pentax Medical CompanyApr 10, 2014
K131902 · PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
- Endochoice, Inc.Oct 10, 2013
K131422 · PEERSCOPE SYSTEM
- United States Endoscopy Group, Inc.Aug 7, 2013
K130148 · FOREIGN BODY HOOD
- Olympus Medical Systems CorporationDec 11, 2012
K123317 · EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
- Fujinon, Inc.Aug 13, 2012
K120446 · FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
- Easyglide , Ltd.May 16, 2012
K113166 · CLEARPATH UPPER GI
- Fujinon, Inc.May 16, 2011
K111243 · FUJINON ULTRASONIC PROCESSOR
- Easyglide , Ltd.Mar 9, 2010
K093779 · CLEARPATH UGI
- Fujinon, Inc.Mar 16, 2007
K063316 · FUJINON MODEL EG-530N TRANS NASAL INSERTION
- Fujinon, Inc.Mar 1, 2007
K063847 · FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
- KARL STORZ Endoscopy-America, Inc.Nov 9, 2006
K060907 · KARL STORZ VIDEO GASTROSCOPES
- Fujinon, Inc.Nov 24, 2004
K042043 · FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
- Olympus Opto-Electronics Co., Ltd.Oct 2, 2003
K032177 · GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
- Olympus Optical Co., Ltd.Jun 19, 2002
K021886 · OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
- Pentax Precision Instrument Corp.Feb 4, 2002
K013640 · EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
- The Olympus Optical Co.May 15, 2001
K011151 · EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
- Olympus Optical Co., Ltd.Jan 30, 2001
K002231 · LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT
- Olympus Optical Co., Ltd.Sep 8, 2000
K001766 · OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
- Olympus America, Inc.Sep 17, 1999
K984358 · OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
- Fiegert-Endotech Medizintechnik GmbHMar 31, 1998
K974493 · FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
- Welch Allyn, Inc.Jul 29, 1997
K971734 · VG 200 VIDEO GASTROSCOPE
- Olympus America, Inc.Jul 25, 1997
K971660 · OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
- Olympus America, Inc.Feb 7, 1997
K963023 · ULTRASOUND GASTROSCOPE GF TYPE UM30P
- Pentax Precision Instrument Corp.Oct 4, 1996
K962897 · EG-3400, VIDEO GASTROSCOPE
- Pentax Precision Instrument Corp.Sep 16, 1996
K962460 · EG-3800T, VIDEO GASTROSCOPE
- Pentax Precision Instrument Corp.Jul 9, 1996
K961564 · EG-2940, VIDEO GASTROSCOPE
- Vision-Sciences, Inc.Feb 24, 1995
K943715 · VISION SYSTEM UPPER G.I. EXDOSCOPE
- Olympus Corp.Nov 2, 1993
K933717 · OLYMPUS MEASURING DEVICES
- Pentax Precision Instrument Corp.Jul 9, 1985
K850020 · PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
- Pentax Precision Instrument Corp.Feb 4, 1984
K833924 · TWO CHANNEL GASTROFIBERSCOPE FG-36T
- Pentax Precision Instrument Corp.Aug 11, 1983
K832007 · PENTAX FG-34JA GASTROFIBERSCOPE