FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T— 510(k) K253137
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K253137 for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T, Substantially Equivalent on 2026-06-16. Applicant: Fujifilm Corporation. Device class: 2.
Summary
Fujifilm's clearance covers two FUJIFILM endoscope models, EB-840S and EB-840T, filed under EOQ, flexible or rigid bronchoscopes. The record doesn't say how the two models differ.
Class II, 21 CFR 874.4680. Ear, Nose, and Throat is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Fujifilm filed from Ashigara Kami-Gun, Japan. The decision came 264 calendar days after receipt (September 25, 2025 to June 16, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashigara Kami-Gun, JP
Recent devices under product code EOQ
view allMore clearances from Fujifilm Corporation
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.