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.
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- 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 all- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)
- K260573 — EvoEndo Single-Use Endoscopy System
- K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
More 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.