FDA 510(k) Applications for Medical Device Product Code "ODG"
(Endoscopic Ultrasound System, Gastroenterology-Urology)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K163058 | BOSTON SCIENTIFIC | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | 01/30/2017 |
| K173184 | Boston Scientific | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | 10/27/2017 |
| K110030 | BOSTON SCIENTIFIC CORP. | EXPECT ENDOSCOPIC ASPIRATION NEEDLE | 01/12/2011 |
| K160845 | BOSTON SCIENTIFIC CORPORATION | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | 05/03/2016 |
| K223616 | Boston Scientific Corporation | AcquireÖ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | 12/30/2022 |
| K112198 | Boston Scientific Corporation | EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | 09/14/2011 |
| K133312 | Boston Scientific Corporation | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | 01/03/2014 |
| K232518 | Endosound, Inc | EndoSound Vision System; EVS | 12/27/2023 |
| K221952 | FUJIFILM Corporation | Endoscope Model EG-580UT and Endoscope Model EG-580UR | 08/04/2022 |
| K183433 | Fujifilm Corporation | FUJIFILM Ultrasonic Endoscope | 09/05/2019 |
| K221238 | FUJIFILM Corporation | FUJIFILM Ultrasonic Endoscope EG-740UT | 08/19/2022 |
| K214089 | Fujifilm Corporation | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | 06/03/2022 |
| K171207 | FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | 01/11/2018 |
| K172309 | Micro-Tech (Nanjing) CO.,Ltd. | Endoscopic Ultrasound Aspiration Needle | 09/29/2017 |
| K212852 | Micro-Tech(Nanjing) Co., Ltd. | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | 12/06/2021 |
| K011886 | OLYMPUS AMERICA, INC. | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, | 08/27/2001 |
| K961048 | OLYMPUS AMERICA, INC. | OLYMPUS MH-246R BALLOON SHEATH | 09/16/1996 |
| K042140 | OLYMPUS CORPORATION | OLYMPUS BF TYPE UC160-OL8 | 08/18/2004 |
| K010591 | OLYMPUS OPTICAL CO., LTD. | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER | 03/15/2001 |
| K031347 | OLYMPUS OPTICAL CO., LTD. | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 | 05/09/2003 |
| K251542 | OnePass Medical Ltd. | InstaFAN | 07/18/2025 |
| K061068 | PENTAX MEDICAL COMPANY | EG-3670URK | 05/03/2006 |
| K090196 | PENTAX MEDICAL COMPANY | EG-3670URK | 05/19/2009 |
| K090197 | PENTAX MEDICAL COMPANY | EG-3870UTK | 05/19/2009 |
| K130206 | PENTAX OF AMERICA, INC. | PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS | 03/20/2013 |
| K130247 | PENTAX OF AMERICA, INC. | PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS | 03/20/2013 |
| K200090 | PENTAX of America, Inc. | 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) | 07/23/2020 |
| K182004 | PENTAX of America, Inc. | PENTAX Medical Endoscopic Ultrasound System | 08/21/2018 |
| K162447 | PENTAX of America, Inc. | 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 | 04/13/2017 |
| K203166 | PENTAX of America, Inc. | 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 | 12/30/2020 |
| K021278 | PENTAX PRECISION INSTRUMENT CORP. | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | 09/06/2002 |
| K023401 | PENTAX PRECISION INSTRUMENT CORP. | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | 02/11/2003 |
| K031789 | PENTAX PRECISION INSTRUMENT CORP. | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | 08/08/2003 |
| K021276 | PENTAX PRECISION INSTRUMENT CORP. | FG-36UX FIBER ULTRASOUND GASTROSCOPE | 09/12/2002 |
| K010740 | PENTAX PRECISION INSTRUMENT CORP. | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | 04/17/2001 |
| K231813 | Sonoscape Medical Corp. | Ultrasonic Gastrovideoscope | 03/08/2024 |
| K982734 | THE OLYMPUS OPTICAL CO. | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE | 10/05/1998 |
| K180731 | United States Endoscopy Group, Inc. (US Endoscopy) | Ultramatrix EUS Balloon | 04/19/2018 |
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