510(k) K862107

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR by Penn Medical Devices, Inc. — Product Code ODC

K862107 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR". The FDA issued a decision of Substantially Equivalent on September 11, 1986. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.