FDA product code ODG: Endoscopic Ultrasound System, Gastroenterology-Urology
ODG is the FDA product code for endoscopic ultrasound system, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 44 510(k) submissions under ODG, 10 in the last five years, from 19 different applicants. The average 510(k) review took 100 days (median 82); 155 days on average over the last three years. FDA has posted 10 recalls for ODG devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for ODG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 100 |
| 2018 | 3 | 105 |
| 2019 | 1 | 268 |
| 2020 | 2 | 128 |
| 2021 | 1 | 90 |
| 2022 | 4 | 81 |
| 2023 | 1 | 131 |
| 2024 | 1 | 261 |
| 2025 | 2 | 84 |
| 2026 | 2 | 120 |
Compare with all 510(k) review times · Search every ODG clearance
Top ODG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax Precision Instrument Corp. | 7 | 2003-08-08 |
| Pentax of America, Inc. | 6 | 2020-12-30 |
| Boston Scientific Corporation | 5 | 2026-06-17 |
| Fujifilm Corporation | 4 | 2022-08-19 |
| Pentax Medical Company | 3 | 2009-05-19 |
14 more applicants have ODG clearances. See the full list in Caduvo.
Most recent ODG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261183 | Olympus Medical Systems Corporation | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | 2026-07-31 | 112 |
| K260428 | Boston Scientific Corporation | RIVOS EUS Access Device (M00553900) | 2026-06-17 | 127 |
| K251859 | Olympus Medical Systems Corporation | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | 2025-10-03 | 108 |
| K251542 | Onepass Medical , Ltd. | InstaFAN | 2025-07-18 | 59 |
| K231813 | Sonoscape Medical Corp. | Ultrasonic Gastrovideoscope | 2024-03-08 | 261 |
Recalls for ODG devices
10 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-10-16.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 4 |
Frequently asked questions
What is FDA product code ODG?
ODG is the FDA product code for endoscopic ultrasound system, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODG?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODG?
Across 44 cleared submissions the average was 100 days from receipt to decision (median 82).
Which companies have the most ODG clearances?
Pentax Precision Instrument Corp. (7); Pentax of America, Inc. (6); Boston Scientific Corporation (5); Fujifilm Corporation (4); Pentax Medical Company (3).
Have ODG devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2020-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code ODG
- Run a recall and safety report across every ODG manufacturer
- Watch product code ODG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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