Product code ODG
- Device name
- Endoscopic Ultrasound System, Gastroenterology-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | 2025-10-03 |
| K251542 | InstaFAN | Onepass Medical , Ltd. | 2025-07-18 |
| K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | 2024-03-08 |
| K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023-12-27 |
| K223616 | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2022-12-30 |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | 2022-08-19 |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | 2022-08-04 |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Fujifilm Corporation | 2022-06-03 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 |
| K203166 | 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 | Pentax of America, Inc. | 2020-12-30 |
| K200090 | 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... | Pentax of America, Inc. | 2020-07-23 |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019-09-05 |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | 2018-08-21 |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) | 2018-04-19 |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 |
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017-10-27 |
| K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017-09-29 |
| K162447 | 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 | Pentax of America, Inc. | 2017-04-13 |
| K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017-01-30 |
| K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2016-05-03 |
| K133312 | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation | 2014-01-03 |
| K130206 | PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS | Pentax of America, Inc. | 2013-03-20 |
| K130247 | PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS | Pentax of America, Inc. | 2013-03-20 |
| K112198 | EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation | 2011-09-14 |
| K110030 | EXPECT ENDOSCOPIC ASPIRATION NEEDLE | Boston Scientific Corp | 2011-01-12 |
| K090196 | EG-3670URK | Pentax Medical Company | 2009-05-19 |
| K090197 | EG-3870UTK | Pentax Medical Company | 2009-05-19 |
| K061068 | EG-3670URK | Pentax Medical Company | 2006-05-03 |
| K042140 | OLYMPUS BF TYPE UC160-OL8 | Olympus Corporation | 2004-08-18 |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2003-08-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850050934189 | EndoSound® EVS™ Band Applicator | Endosound, Inc. | 2024-08-30 |
| 00191506030742 | Acquire™ S | BOSTON SCIENTIFIC CORPORATION | 2024-05-16 |
| 00191506030759 | Acquire™ S | BOSTON SCIENTIFIC CORPORATION | 2024-05-15 |
| 00191506021931 | iNod™ | BOSTON SCIENTIFIC CORPORATION | 2023-03-21 |
| 00191506021924 | iNod™ | BOSTON SCIENTIFIC CORPORATION | 2023-03-21 |
| 00191506020934 | iNod™ | BOSTON SCIENTIFIC CORPORATION | 2023-03-21 |
| 00191506020927 | iNod™ Ultrasound Guidance Conso | BOSTON SCIENTIFIC CORPORATION | 2023-03-21 |
| 04547410446142 | FUJIFILM | FUJIFILM CORPORATION | 2022-09-19 |
| 04547410416176 | FUJIFILM | FUJIFILM CORPORATION | 2022-09-19 |
| 04547410446128 | FUJIFILM | FUJIFILM CORPORATION | 2022-09-19 |
| 04547410445886 | FUJIFILM | FUJIFILM CORPORATION | 2022-06-20 |
| 00724995180775 | Ultramatrix | US Endoscopy | 2020-04-02 |
| 00724995180768 | Ultramatrix | US Endoscopy | 2020-04-02 |
| 04547410349061 | FUJIFILM | FUJIFILM CORPORATION | 2019-09-30 |
| 04547410349078 | FUJIFILM | FUJIFILM CORPORATION | 2019-09-30 |
| 04547410342741 | FUJIFILM | FUJIFILM CORPORATION | 2018-02-23 |
| 04547410343052 | FUJIFILM | FUJIFILM CORPORATION | 2018-02-23 |
| 04953170057847 | CLEANING ADAPTER FOR INSTRUMENT CHANNELPORT | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-12 |
| 04953170053870 | Balloon2 | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 08714729931829 | Acquire | BOSTON SCIENTIFIC CORPORATION | 2017-03-01 |
| 08714729931805 | Acquire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729931782 | Acquire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729848172 | Expect Slimline SL | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729848165 | Expect Slimline SL | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729848158 | Expect Slimline SL | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729848141 | Expect Slimline SL | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729797463 | Expect | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729790051 | Expect | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729790044 | Expect | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729790020 | Expect | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |