Panels › Gastroenterology, Urology › Product code ODG · Class 2
Endoscopic Ultrasound System, Gastroenterology-Urology
Regulation 876.1500
2510(k)s in 12 months (44 all time)
4recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in ODG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) Olympus Medical Systems Corporation, JP | ODG |
| Jun 17, 2026 | K260428 | RIVOS EUS Access Device (M00553900) Boston Scientific Corporation | ODG |
| Oct 3, 2025 | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) Olympus Medical Systems Corporation, JP | ODG |
| Jul 18, 2025 | K251542 | InstaFAN Onepass Medical , Ltd., IL | ODG |
| Mar 8, 2024 | K231813 | Ultrasonic Gastrovideoscope Sonoscape Medical Corp., CN | ODG |
| Dec 27, 2023 | K232518 | EndoSound Vision System; EVS Endosound, Inc. | ODG |
| Dec 30, 2022 | K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Boston Scientific Corporation | ODG |
| Aug 19, 2022 | K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT Fujifilm Corporation, JP | ODG |
| Aug 4, 2022 | K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR Fujifilm Corporation, JP | ODG |
| Jun 3, 2022 | K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 Fujifilm Corporation, JP | ODG |
| Dec 6, 2021 | K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd., CN | ODG |
| Dec 30, 2020 | K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PEN Pentax of America, Inc. | ODG |
| Jul 23, 2020 | K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG3 Pentax of America, Inc. | ODG |
| Sep 5, 2019 | K183433 | FUJIFILM Ultrasonic Endoscope Fujifilm Corporation, JP | ODG |
| Aug 21, 2018 | K182004 | PENTAX Medical Endoscopic Ultrasound System Pentax of America, Inc. | ODG |
| Apr 19, 2018 | K180731 | Ultramatrix EUS Balloon United States Endoscopy Group, Inc. (Us Endoscopy) | ODG |
| Jan 11, 2018 | K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M Fujifilm Medical Systems U.S.A, Inc. | ODG |
| Oct 27, 2017 | K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle Boston Scientific | ODG |
| Sep 29, 2017 | K172309 | Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd., CN | ODG |
| Apr 13, 2017 | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video P Pentax of America, Inc. | ODG |
| Jan 30, 2017 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle Boston Scientific | ODG |
| May 3, 2016 | K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Boston Scientific Corporation | ODG |
| Jan 3, 2014 | K133312 | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation | ODG |
| Mar 20, 2013 | K130247 | PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS Pentax of America, Inc. | ODG |
| Mar 20, 2013 | K130206 | PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS Pentax of America, Inc. | ODG |
| Sep 14, 2011 | K112198 | EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation | ODG |
| Jan 12, 2011 | K110030 | EXPECT ENDOSCOPIC ASPIRATION NEEDLE Boston Scientific Corp | ODG |
| May 19, 2009 | K090197 | EG-3870UTK Pentax Medical Company | ODG |
| May 19, 2009 | K090196 | EG-3670URK Pentax Medical Company | ODG |
| May 3, 2006 | K061068 | EG-3670URK Pentax Medical Company | ODG |
| Aug 18, 2004 | K042140 | OLYMPUS BF TYPE UC160-OL8 Olympus Corporation | ODG |
| Aug 8, 2003 | K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| May 9, 2003 | K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 Olympus Optical Co., Ltd. | ODG |
| Feb 11, 2003 | K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Sep 12, 2002 | K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Sep 6, 2002 | K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Aug 27, 2001 | K011886 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, Olympus America, Inc. | ODG |
| Apr 17, 2001 | K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Mar 15, 2001 | K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER Olympus Optical Co., Ltd., JP | ODG |
| Oct 5, 1998 | K982734 | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE The Olympus Optical Co. | ODG |
| Sep 16, 1996 | K961048 | OLYMPUS MH-246R BALLOON SHEATH Olympus America, Inc. | ODG |
| Nov 24, 1995 | K953876 | PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) Pentax Precision Instrument Corp. | ODG |
| Aug 16, 1993 | K926514 | ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 Olympus Corp. | ODG |
| Jun 12, 1991 | K904573 | PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA Pentax Precision Instrument Corp. | ODG |
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