EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)— 510(k) K261183
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K261183 for EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190), Substantially Equivalent on 2026-07-31. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Summary
Olympus Medical Systems' EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is filed under ODG, endoscopic ultrasound systems for gastroenterology and urology. The record gives the model as GF-UE190 but no other specs.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Olympus filed from Tokyo, Japan. Review took 112 calendar days (April 10 to July 31, 2026).
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Product code ODG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code ODG
view allMore clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
Adverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.