510(k) · Cleared
ClearedOlympus Ultrasonic Gastrovideoscope GF Type UC140P-DO5 & Olympus Ultrasonic Gastrofiberscope GF Type UC30P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Jun 19, 2002 after a 12-day review. The FDA summary names no predicate by number.
- Decided
- Jun 19, 2002
- Review
- 12 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
The Olympus GF-UC140P-DO5 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic…
Read the full statement (153 words)
The Olympus GF-UC140P-DO5 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.
The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021886: Olympus Ultrasonic Gastrovideoscope GF Type UC140P-DO5 & Olympus Ultrasonic Gastrofiberscope GF Type UC30P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021886
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026