# ODG: Endoscopic Ultrasound System, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 44
- 510(k) review time 2021–2025: median 108 days (middle half 59–131)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 3
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 4
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K926514: Endoscopic Ultrasound System Type 20 (1993), cited by 6
- K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160, (2001), cited by 3
- K133312: Expect Slimline Endoscopic Ultrasound Aspiration Needle (2014), cited by 3
- K023401: EG-3830UT, Video Ultrasound Gastroscope (2003), cited by 3
- K160845: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (2016), cited by 3
- K042140: Olympus BF Type UC160-OL8 (2004), cited by 3
- K961048: Olympus MH-246R Balloon Sheath (1996), cited by 3
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center (2001), cited by 3
- K010740: FG-36UX, Fiber Ultrasound Gastroscope (2001), cited by 2
- 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) (2020), cited by 2

Source page: https://510kreport.com/product-code/ODG
Data by year (CSV): https://510kreport.com/product-code/ODG.csv