510(k) K252247— Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

Substantially Equivalent

Olympus Medical Systems Corporation

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2025-07-18
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.