Atlas FDA

FDS

76 FDA 510(k) clearances · Product code

133 daysmedian time to decision
258 days90th percentile
76clearances measured

FDA profile

Official device name
Gastroscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 1,755 · 2022: 6,216 · 2023: 9,874 · 2024: 9,258 · 2025: 19,078 · 2026: 24,200
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702)Intuitive Surgical, Inc.2026-08-07
EvoEndo Single-Use Endoscopy System (K260573)EvoEndo, Inc.2026-04-21
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (K250550)Fujifilm Corporation2026-02-17
Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (K253568)Fujifilm Corporation2026-02-06
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) (K251256)Pentax of America, Inc.2025-12-16
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (K251041)Actuated Medical, Inc.2025-10-31
EvoEndo Single-Use Endoscopy System (K251708)EvoEndo, Inc.2025-10-10
Disposable Distal Cap (K243388)Micro-Tech (Nanjing) Co., Ltd.2025-06-27
EvoEndo Single-Use Endoscopy System (K250900)EvoEndo, Inc.2025-06-16
FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K243512)Fujifilm Corporation2025-06-10
Endoscopic Distal Attachment (AF-D series) (K242635)Alton (Shanghai) Medical Instruments Co., Ltd.2025-05-30
Disposable Distal Attachment D-201 Series (K250296)Olympus Medical Systems Corp.2025-05-01
PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (K241213)Pentax of America, Inc.2024-12-06
Hood (DH-083ST) (K242779)Fujifilm Corporation2024-10-11
FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K240142)Fujifilm Corporation2024-09-04
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 (K232997)Olympus Medical Systems Corporation2024-06-19
Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 (K232919)Ambu A/S2024-04-05
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) (K232028)Iq Endoscopes Limited2023-11-17
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) (K232314)FUJIFILM Healthcare Americas Corporation2023-09-01
FUJIFILM Endoscope Model EI-740D/S (K221551)Fujifilm Corporaton2023-01-27
EvoEndo Single-Use Endoscopy System (K213606)EvoEndo, Inc.2022-02-14
Ambu® aScope™ Gastro, Ambu® aBox™2 (K212382)Ambu A/S2022-02-03
PENTAX Medical Video Upper GI Scopes EG17-J10 (K210177)Pentax of America, Inc.2021-10-20
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 (K212296)Fujifilm Corporation2021-08-19
Pathfinder Endoscope Cap (K210915)Neptune Medical, Inc.2021-05-25
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) (K210485)Pentax of America, Inc.2021-05-13
Endoscope Model EI-740D/S (K210162)Fujifilm Corporation2021-04-09
Endofresh Digestive Endoscopy System (K192704)Huizhou Xzing Technology Co., Ltd.2020-09-02
Fujifilm Ultrasonic Processor (K200850)Fujifilm Corporation2020-07-06
FUJIFILM Distal Cap Models 33-40 (K193123)Fujifilm Corporation2019-12-11
PENTAX Medical Video Upper GI Scopes (EG Family) (K190799)Pentax of America, Inc.2019-11-12
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L (K183572)Fujifilm Corporation2019-07-16
FUJIFILM Endoscope Model EG-740N (K182836)Fujifilm Corporation2019-04-02
FUJIFILM Endoscope Model EG-530N (K183686)Fujifilm Corporation2019-02-28
PENTAX Video Upper G.I. Scope EG34-i10 (K180292)Pentax Medical of America, Inc.2018-10-12
FUJIFILM 600 Series Endoscope EG-600WR v2 (K180341)Fujifilm Corporation2018-08-03
FUJIFILM Ultrasonic Endoscope (K181763)Fujifilm Corporation2018-07-27
Visura Technologies TEECAD System (K180911)Visura Technologies, LLC2018-06-20
SB Soft Hood - Straight type, SB Soft Hood - Undercut type (K173004)Sumitomo Bakelite Co., Ltd.2018-05-08
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (K172916)Fujifilm Corporation2018-03-01
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749)Fujifilm Medical Systems U.S.A, Inc.2017-06-15
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (K153206)Fujifilm Medical System U.S.A., Inc.2016-03-03
Fuse Gastroscopy System (K152182)Endochoice, Inc.2015-12-10
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (K142629)Fujifilm Medical System U.S.A., Inc.2015-05-14
GIS ENDOSCOPIC OPTICAL LENS (K140295)Gi Scientific, LLC2014-07-24
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) (K131902)Pentax Medical Company2014-04-10
PEERSCOPE SYSTEM (K131422)Endochoice, Inc.2013-10-10
FOREIGN BODY HOOD (K130148)United States Endoscopy Group, Inc.2013-08-07
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N (K123317)Olympus Medical Systems Corporation2012-12-11
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 (K120446)Fujinon, Inc.2012-08-13
CLEARPATH UPPER GI (K113166)Easyglide , Ltd.2012-05-16
FUJINON ULTRASONIC PROCESSOR (K111243)Fujinon, Inc.2011-05-16
CLEARPATH UGI (K093779)Easyglide , Ltd.2010-03-09
FUJINON MODEL EG-530N TRANS NASAL INSERTION (K063316)Fujinon, Inc.2007-03-16
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 (K063847)Fujinon, Inc.2007-03-01
KARL STORZ VIDEO GASTROSCOPES (K060907)KARL STORZ Endoscopy-America, Inc.2006-11-09
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 (K042043)Fujinon, Inc.2004-11-24
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I (K032177)Olympus Opto-Electronics Co., Ltd.2003-10-02
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P (K021886)Olympus Optical Co., Ltd.2002-06-19
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (K013640)Pentax Precision Instrument Corp.2002-02-04
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (K011151)The Olympus Optical Co.2001-05-15
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT (K002231)Olympus Optical Co., Ltd.2001-01-30
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE (K001766)Olympus Optical Co., Ltd.2000-09-08
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 (K984358)Olympus America, Inc.1999-09-17
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES (K974493)Fiegert-Endotech Medizintechnik GmbH1998-03-31
VG 200 VIDEO GASTROSCOPE (K971734)Welch Allyn, Inc.1997-07-29
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT (K971660)Olympus America, Inc.1997-07-25
ULTRASOUND GASTROSCOPE GF TYPE UM30P (K963023)Olympus America, Inc.1997-02-07
EG-3400, VIDEO GASTROSCOPE (K962897)Pentax Precision Instrument Corp.1996-10-04
EG-3800T, VIDEO GASTROSCOPE (K962460)Pentax Precision Instrument Corp.1996-09-16
EG-2940, VIDEO GASTROSCOPE (K961564)Pentax Precision Instrument Corp.1996-07-09
VISION SYSTEM UPPER G.I. EXDOSCOPE (K943715)Vision-Sciences, Inc.1995-02-24
OLYMPUS MEASURING DEVICES (K933717)Olympus Corp.1993-11-02
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 (K850020)Pentax Precision Instrument Corp.1985-07-09
TWO CHANNEL GASTROFIBERSCOPE FG-36T (K833924)Pentax Precision Instrument Corp.1984-02-04
PENTAX FG-34JA GASTROFIBERSCOPE (K832007)Pentax Precision Instrument Corp.1983-08-11

Track FDS automatically

Every clearance here is in the API, with alerts when new ones post.