510(k) K123319

GYRUS ACMI BICOAG HEMOSTASIS PROBE by Olympus Surgical Technologies America — Product Code KNS

K123319 is an FDA 510(k) premarket notification submitted by Olympus Surgical Technologies America for the device "GYRUS ACMI BICOAG HEMOSTASIS PROBE". The FDA issued a decision of Substantially Equivalent on December 14, 2012. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Olympus Surgical Technologies America has at least 10 other 510(k) clearances on record.