Fujifilm Corporation · Class II · Cleared Feb 6, 2026
| K-number | K253568 |
| Device name | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR |
| Applicant | Fujifilm Corporation |
| Product code | FDS |
| Device class | Class II |
| Decision date | Feb 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Hood DH-084STR through DH-134STR are endoscope accessories designed to attach to the tip of an endoscope and maintain the field of view during endoscopic procedures or examinations. They are specifically intended to prevent mucosa from obstructing the surgical field during digestive tract observation, endoscopic mucosal resection (EMR), and endoscopic submucosal dissection (ESD).
The proposed devices differ from the predicate in outer diameter, maximum diameter of the attaching endoscope, distance from tip, and total length. The material construction also differs from the predicate device but has been evaluated through biocompatibility testing with no new safety or efficacy concerns identified.
Endoscope-specific testing was conducted according to ISO 8600-1:2015. Performance testing included measurements of outer diameter, maximum diameter of attaching endoscope portion, total length, and distance from the tip using a scale.
The changes to the proposed device dimensions and materials do not affect safety or efficacy because compatibility verification was performed using worst-case endoscope specifications, and performance testing confirmed the new hood model met all test objectives and is substantially equivalent to the predicate devices.
View the full FDA submission: accessdata.fda.gov