FDA Product Code
FDA Product Code ODG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | 2026-07-31 | Traditional | PDF ↗ |
| K260428 | RIVOS EUS Access Device (M00553900) | Boston Scientific Corporation | 2026-06-17 | Traditional | PDF ↗ |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | 2025-10-03 | Traditional | PDF ↗ |
| K251542 | InstaFAN | Onepass Medical , Ltd. | 2025-07-18 | Traditional | PDF ↗ |
| K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | 2024-03-08 | Traditional | PDF ↗ |
| K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023-12-27 | Traditional | PDF ↗ |
| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2022-12-30 | Special | PDF ↗ |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | 2022-08-19 | Traditional | PDF ↗ |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | 2022-08-04 | Special | PDF ↗ |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Fujifilm Corporation | 2022-06-03 | Traditional | PDF ↗ |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| 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 Type) | Pentax of America, Inc. | 2020-07-23 | Traditional | PDF ↗ |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019-09-05 | Traditional | PDF ↗ |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | 2018-08-21 | Special | PDF ↗ |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) | 2018-04-19 | Special | PDF ↗ |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 | Traditional | PDF ↗ |
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017-10-27 | Special | PDF ↗ |
| K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017-09-29 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017-01-30 | Traditional | PDF ↗ |
| K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2016-05-03 | Special | PDF ↗ |
| K133312 | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation | 2014-01-03 | Special | PDF ↗ |
| K130247 | PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS | Pentax of America, Inc. | 2013-03-20 | Special | PDF ↗ |
| K130206 | PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS | Pentax of America, Inc. | 2013-03-20 | Special | PDF ↗ |
| K112198 | EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation | 2011-09-14 | Special | PDF ↗ |
| K110030 | EXPECT ENDOSCOPIC ASPIRATION NEEDLE | Boston Scientific Corp | 2011-01-12 | Special | PDF ↗ |
| K090196 | EG-3670URK | Pentax Medical Company | 2009-05-19 | Traditional | PDF ↗ |
| K090197 | EG-3870UTK | Pentax Medical Company | 2009-05-19 | Traditional | PDF ↗ |
| K061068 | EG-3670URK | Pentax Medical Company | 2006-05-03 | Traditional | PDF ↗ |
| K042140 | OLYMPUS BF TYPE UC160-OL8 | Olympus Corporation | 2004-08-18 | Traditional | PDF ↗ |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2003-08-08 | Traditional | PDF ↗ |
| K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 | Olympus Optical Co., Ltd. | 2003-05-09 | Traditional | PDF ↗ |
| K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2003-02-11 | Traditional | PDF ↗ |
| K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2002-09-12 | Traditional | PDF ↗ |
| K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 2002-09-06 | Traditional | PDF ↗ |
| K011886 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, | Olympus America, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2001-04-17 | Traditional | PDF ↗ |
| K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER | Olympus Optical Co., Ltd. | 2001-03-15 | Traditional | PDF ↗ |
| K982734 | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE | The Olympus Optical Co. | 1998-10-05 | Traditional | PDF ↗ |
| K961048 | OLYMPUS MH-246R BALLOON SHEATH | Olympus America, Inc. | 1996-09-16 | Traditional | PDF ↗ |
| K953876 | PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) | Pentax Precision Instrument Corp. | 1995-11-24 | Traditional | PDF ↗ |
| K926514 | ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 | Olympus Corp. | 1993-08-16 | Traditional | PDF ↗ |
| K904573 | PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA | Pentax Precision Instrument Corp. | 1991-06-12 | Traditional | PDF ↗ |
Product code ODG · Class II · Gastroenterology, Urology. Data: openFDA.