510(k) K894861

WILTEK PAPILLOTOME by Wiltek Medical, Inc. — Product Code KNS

K894861 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK PAPILLOTOME". The FDA issued a decision of Substantially Equivalent on December 21, 1989. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.