510(k) K081640

GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS by Gimmi GmbH — Product Code HCH

K081640 is an FDA 510(k) premarket notification submitted by Gimmi GmbH for the device "GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS". The FDA issued a decision of Substantially Equivalent on May 6, 2009. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Gimmi GmbH has at least 5 other 510(k) clearances on record.