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)

510(k) number: K252247
Device name: 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)
Applicant: Olympus Medical Systems Corporation JP
Product code: FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
Decision date: 2025-10-16
Date received: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K252247.pdf

Official FDA record: K252247

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.