510(k) K973584

MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM by Medtech Instruments — Product Code ESW

K973584 is an FDA 510(k) premarket notification submitted by Medtech Instruments for the device "MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 9, 1998. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Medtech Instruments has at least 1 other 510(k) clearance on record.