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) by Olympus Medical Systems Corporation — Product Code FBK

K252247 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "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)". The FDA issued a decision of Substantially Equivalent on October 16, 2025. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.