510(k) K123170

VARI-PASS VARIABLE LENGTH ACCESS SHEATH by Olympus Surgical Technologies America — Product Code KNY

K123170 is an FDA 510(k) premarket notification submitted by Olympus Surgical Technologies America for the device "VARI-PASS VARIABLE LENGTH ACCESS SHEATH". The FDA issued a decision of Substantially Equivalent on February 4, 2013. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Olympus Surgical Technologies America has at least 10 other 510(k) clearances on record.