Atlas FDA

ODG

44 FDA 510(k) clearances · Product code

90 daysmedian time to decision
229 days90th percentile
44clearances measured

FDA profile

Official device name
Endoscopic Ultrasound System, Gastroenterology-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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: 1,234 · 2022: 1,832 · 2023: 2,078 · 2024: 1,904 · 2025: 3,581 · 2026: 4,924
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K261183)Olympus Medical Systems Corporation2026-07-31
RIVOS™ EUS Access Device (M00553900) (K260428)Boston Scientific Corporation2026-06-17
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K251859)Olympus Medical Systems Corporation2025-10-03
InstaFAN (K251542)Onepass Medical , Ltd.2025-07-18
Ultrasonic Gastrovideoscope (K231813)Sonoscape Medical Corp.2024-03-08
EndoSound Vision System; EVS (K232518)Endosound, Inc.2023-12-27
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616)Boston Scientific Corporation2022-12-30
FUJIFILM Ultrasonic Endoscope EG-740UT (K221238)Fujifilm Corporation2022-08-19
Endoscope Model EG-580UT and Endoscope Model EG-580UR (K221952)Fujifilm Corporation2022-08-04
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (K214089)Fujifilm Corporation2022-06-03
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle (K212852)Micro-Tech (Nanjing) Co., Ltd.2021-12-06
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K203166)Pentax of America, Inc.2020-12-30
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (K200090)Pentax of America, Inc.2020-07-23
FUJIFILM Ultrasonic Endoscope (K183433)Fujifilm Corporation2019-09-05
PENTAX Medical Endoscopic Ultrasound System (K182004)Pentax of America, Inc.2018-08-21
Ultramatrix EUS Balloon (K180731)United States Endoscopy Group, Inc. (Us Endoscopy)2018-04-19
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207)Fujifilm Medical Systems U.S.A, Inc.2018-01-11
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K173184)Boston Scientific2017-10-27
Endoscopic Ultrasound Aspiration Needle (K172309)Micro-Tech (Nanjing) Co., Ltd.2017-09-29
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner (K162447)Pentax of America, Inc.2017-04-13
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058)Boston Scientific2017-01-30
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845)Boston Scientific Corporation2016-05-03
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K133312)Boston Scientific Corporation2014-01-03
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130206)Pentax of America, Inc.2013-03-20
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130247)Pentax of America, Inc.2013-03-20
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K112198)Boston Scientific Corporation2011-09-14
EXPECT ENDOSCOPIC ASPIRATION NEEDLE (K110030)Boston Scientific Corp2011-01-12
EG-3870UTK (K090197)Pentax Medical Company2009-05-19
EG-3670URK (K090196)Pentax Medical Company2009-05-19
EG-3670URK (K061068)Pentax Medical Company2006-05-03
OLYMPUS BF TYPE UC160-OL8 (K042140)Olympus Corporation2004-08-18
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (K031789)Pentax Precision Instrument Corp.2003-08-08
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (K031347)Olympus Optical Co., Ltd.2003-05-09
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (K023401)Pentax Precision Instrument Corp.2003-02-11
FG-36UX FIBER ULTRASOUND GASTROSCOPE (K021276)Pentax Precision Instrument Corp.2002-09-12
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (K021278)Pentax Precision Instrument Corp.2002-09-06
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, (K011886)Olympus America, Inc.2001-08-27
FG-36UX, FIBER ULTRASOUND GASTROSCOPE (K010740)Pentax Precision Instrument Corp.2001-04-17
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER (K010591)Olympus Optical Co., Ltd.2001-03-15
OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE (K982734)The Olympus Optical Co.1998-10-05
OLYMPUS MH-246R BALLOON SHEATH (K961048)Olympus America, Inc.1996-09-16
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) (K953876)Pentax Precision Instrument Corp.1995-11-24
ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 (K926514)Olympus Corp.1993-08-16
PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA (K904573)Pentax Precision Instrument Corp.1991-06-12

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