510(k) K093079

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U by Hobbs Medical, Inc. — Product Code KNS

K093079 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U". The FDA issued a decision of Substantially Equivalent on August 2, 2010. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.