FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit— 510(k) K250550
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K250550 for FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit, Substantially Equivalent on 2026-02-17. Applicant: Fujifilm Corporation. Device class: 2.
Summary
Fujifilm's record names the FUJIFILM Endoscope Model EG-S100XT and the VS-1000 Display Unit together, under product code FDS (Gastroscope And Accessories, Flexible/Rigid). The record doesn't describe either one beyond the name and that code name.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Fujifilm filed from Ashigara Kami-Gun, Japan. Review took 357 calendar days (February 25, 2025 to February 17, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashigara Kami-Gun, JP
Recent devices under product code FDS
view allMore clearances from Fujifilm Corporation
view allAdverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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.