510(k) K101592

ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM by Cheng Medical, Corporation — Product Code GXD

K101592 is an FDA 510(k) premarket notification submitted by Cheng Medical, Corporation for the device "ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 2011. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400.