510(k) K011484

OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 by Olympus Optical Co., Ltd. — Product Code FBK

K011484 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Optical Co., Ltd. has at least 10 other 510(k) clearances on record.