Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR— 510(k) K253568

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K253568 for Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR, Substantially Equivalent on 2026-02-06. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-17
Decision date: 2026-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.