ODG — Endoscopic Ultrasound System, Gastroenterology-Urology Class II
Classification Details
- Product Code
- ODG
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251859 | olympus medical systems corporation | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | October 3, 2025 |
| K251542 | onepass medical | InstaFAN | July 18, 2025 |
| K231813 | sonoscape medical | Ultrasonic Gastrovideoscope | March 8, 2024 |
| K232518 | endosound | EndoSound Vision System; EVS | December 27, 2023 |
| K223616 | boston scientific corporation | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | December 30, 2022 |
| K221238 | fujifilm corporation | FUJIFILM Ultrasonic Endoscope EG-740UT | August 19, 2022 |
| K221952 | fujifilm corporation | Endoscope Model EG-580UT and Endoscope Model EG-580UR | August 4, 2022 |
| K214089 | fujifilm corporation | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | June 3, 2022 |
| K212852 | micro-tech (nanjing) co | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic | December 6, 2021 |
| K203166 | pentax of america | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultraso | December 30, 2020 |
| K200090 | pentax of america | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper | July 23, 2020 |
| K183433 | fujifilm corporation | FUJIFILM Ultrasonic Endoscope | September 5, 2019 |
| K182004 | pentax of america | PENTAX Medical Endoscopic Ultrasound System | August 21, 2018 |
| K180731 | united states endoscopy group, inc. (us endoscopy) | Ultramatrix EUS Balloon | April 19, 2018 |
| K171207 | fujifilm medical systems u.s.a | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | January 11, 2018 |
| K173184 | boston scientific | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | October 27, 2017 |
| K172309 | micro-tech (nanjing) co | Endoscopic Ultrasound Aspiration Needle | September 29, 2017 |
| K162447 | pentax of america | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (C | April 13, 2017 |
| K163058 | boston scientific | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | January 30, 2017 |
| K160845 | boston scientific corporation | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | May 3, 2016 |