510(k) K963852

KSEA THERMOCOAGULATOR (MODEL 265100 20) by KARL STORZ Endoscopy-America, Inc. — Product Code HGI

K963852 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA THERMOCOAGULATOR (MODEL 265100 20)". The FDA issued a decision of Substantially Equivalent on December 10, 1996. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.