510(k) K860941

DISPOSABLE HEATED WIRE LOOPS 48 AND 72 by Intec Medical, Inc. — Product Code BZE

K860941 is an FDA 510(k) premarket notification submitted by Intec Medical, Inc. for the device "DISPOSABLE HEATED WIRE LOOPS 48 AND 72". The FDA issued a decision of Substantially Equivalent on April 2, 1986. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Intec Medical, Inc. has at least 10 other 510(k) clearances on record.