Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2— 510(k) K212296

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K212296 for Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2, Substantially Equivalent on 2021-08-19. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-22
Decision date: 2021-08-19
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.