FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000— 510(k) K251861
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K251861 for FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000, Substantially Equivalent on 2026-03-09. Applicant: Fujifilm Corporation. Device class: 2.
Summary
Fujifilm's record names two FUJIFILM endoscopes, models ED-S100TP and ED-S100XP, and the FUJIFILM Processor Model VS-1000. They're filed under FDT, flexible or rigid duodenoscopes and accessories.
Class II, 21 CFR 876.1500. It was a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
Fujifilm filed from Ashigara Kami-Gun, Japan. The decision came 265 calendar days after FDA received it (June 17, 2025 to March 9, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code FDT
- 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
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More clearances from Fujifilm Corporation
view allAdverse events under product code FDT
product code FDT- Death
- 86
- Injury
- 1,954
- Malfunction
- 14,912
- Total
- 16,952
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.