510(k) K113088

HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) by Innerspace, Inc. — Product Code GWM

K113088 is an FDA 510(k) premarket notification submitted by Innerspace, Inc. for the device "HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Innerspace, Inc. has at least 7 other 510(k) clearances on record.