ClearanceBrief
Panels › Gastroenterology, Urology › Product code FDS · Class 2

Gastroscope And Accessories, Flexible/Rigid

Regulation 876.1500

8510(k)s in 12 months (79 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in FDS

Company510(k)sRecalls
Fujifilm Corporation150
Pentax Precision Instrument Corp.70
Fujinon, Inc.51
Pentax of America, Inc.51
Olympus Medical Systems Corp.50
Olympus Corporation of the Americas05
EvoEndo, Inc.40
Olympus Optical Co., Ltd.40
Ambu A/S30
Olympus America, Inc.30
Decided510(k)Device and applicantCode
Sep 16, 2026K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large
Ambu A/S, DK
FDS
Aug 27, 2026K260856Disposable Distal Attachment D-201-13404
Olympus Medical Systems Corporation, JP
FDS
Aug 27, 2026K260824Gastrointestinal Videoscope Olympus GIF-2T1500
Olympus Medical Systems Corporation, JP
FDS
Aug 7, 2026K253702Intuitive Endoluminal Gastrointestinal System (IG1000)
Intuitive Surgical, Inc.
FDS
Apr 21, 2026K260573EvoEndo Single-Use Endoscopy System
EvoEndo, Inc.
FDS
Feb 17, 2026K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
Fujifilm Corporation, JP
FDS
Feb 6, 2026K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
Fujifilm Corporation, JP
FDS
Dec 16, 2025K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
Pentax of America, Inc.
FDS
Oct 31, 2025K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
Actuated Medical, Inc.
FDS
Oct 10, 2025K251708EvoEndo Single-Use Endoscopy System
EvoEndo, Inc.
FDS
Jun 27, 2025K243388Disposable Distal Cap
Micro-Tech (Nanjing) Co., Ltd., CN
FDS
Jun 16, 2025K250900EvoEndo Single-Use Endoscopy System
EvoEndo, Inc.
FDS
Jun 10, 2025K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
Fujifilm Corporation, JP
FDS
May 30, 2025K242635Endoscopic Distal Attachment (AF-D series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
FDS
May 1, 2025K250296Disposable Distal Attachment D-201 Series
Olympus Medical Systems Corp., JP
FDS
Dec 6, 2024K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
Pentax of America, Inc.
FDS
Oct 11, 2024K242779Hood (DH-083ST)
Fujifilm Corporation, JP
FDS
Sep 4, 2024K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
Fujifilm Corporation, JP
FDS
Jun 19, 2024K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
Olympus Medical Systems Corporation, JP
FDS
Apr 5, 2024K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2
Ambu A/S, DK
FDS
Nov 17, 2023K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
Iq Endoscopes Limited, GB
FDS
Sep 1, 2023K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
FUJIFILM Healthcare Americas Corporation
FDS
Jan 27, 2023K221551FUJIFILM Endoscope Model EI-740D/S
Fujifilm Corporaton, JP
FDS
Feb 14, 2022K213606EvoEndo Single-Use Endoscopy System
EvoEndo, Inc.
FDS
Feb 3, 2022K212382Ambu® aScope™ Gastro, Ambu® aBox™2
Ambu A/S, DK
FDS
Oct 20, 2021K210177PENTAX Medical Video Upper GI Scopes EG17-J10
Pentax of America, Inc.
FDS
Aug 19, 2021K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
Fujifilm Corporation, JP
FDS
May 25, 2021K210915Pathfinder Endoscope Cap
Neptune Medical, Inc.
FDS
May 13, 2021K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
Pentax of America, Inc.
FDS
Apr 9, 2021K210162Endoscope Model EI-740D/S
Fujifilm Corporation, JP
FDS
Sep 2, 2020K192704Endofresh Digestive Endoscopy System
Huizhou Xzing Technology Co., Ltd., CN
FDS
Jul 6, 2020K200850Fujifilm Ultrasonic Processor
Fujifilm Corporation, JP
FDS
Dec 11, 2019K193123FUJIFILM Distal Cap Models 33-40
Fujifilm Corporation, JP
FDS
Nov 12, 2019K190799PENTAX Medical Video Upper GI Scopes (EG Family)
Pentax of America, Inc.
FDS
Jul 16, 2019K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
Fujifilm Corporation, JP
FDS
Apr 2, 2019K182836FUJIFILM Endoscope Model EG-740N
Fujifilm Corporation, JP
FDS
Feb 28, 2019K183686FUJIFILM Endoscope Model EG-530N
Fujifilm Corporation, JP
FDS
Oct 12, 2018K180292PENTAX Video Upper G.I. Scope EG34-i10
Pentax Medical of America, Inc.
FDS
Aug 3, 2018K180341FUJIFILM 600 Series Endoscope EG-600WR v2
Fujifilm Corporation, JP
FDS
Jul 27, 2018K181763FUJIFILM Ultrasonic Endoscope
Fujifilm Corporation, JP
FDS
Jun 20, 2018K180911Visura Technologies TEECAD System
Visura Technologies, LLC
FDS
May 8, 2018K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type
Sumitomo Bakelite Co., Ltd., JP
FDS
Mar 1, 2018K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
Fujifilm Corporation, JP
FDS
Jun 15, 2017K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
Fujifilm Medical Systems U.S.A, Inc.
FDS
Mar 3, 2016K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
Fujifilm Medical System U.S.A., Inc.
FDS
Dec 10, 2015K152182Fuse Gastroscopy System
Endochoice, Inc.
FDS
May 14, 2015K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
Fujifilm Medical System U.S.A., Inc.
FDS
Jul 24, 2014K140295GIS ENDOSCOPIC OPTICAL LENS
Gi Scientific, LLC
FDS
Apr 10, 2014K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
Pentax Medical Company
FDS
Oct 10, 2013K131422PEERSCOPE SYSTEM
Endochoice, Inc., IL
FDS

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