FDA Product Code HCG: Device, Neurovascular Embolization
Under FDA product code HCG, neurovascular embolization devices are cleared for the endovascular treatment of intracranial aneurysms and other neurovascular lesions.
These devices — including detachable coils, flow diverters, and intrasaccular implants — are delivered through microcatheters navigated into the cerebral vasculature to occlude aneurysm sacs or redirect blood flow away from the weakened vessel wall, preventing rupture.
HCG devices are Class II medical devices, regulated under 21 CFR 882.5950 and reviewed by the FDA Neurology panel.
Leading manufacturers include Stryker Neurovascular, Balt USA, LLC and MicroPort NeuroTech (Shanghai) Co., Ltd..
FDA 510(k) Cleared Device, Neurovascular Embolization Devices (Product Code HCG)
About Product Code HCG - Regulatory Context
510(k) Submission Activity
184 total 510(k) submissions under product code HCG since 1987, with 184 receiving FDA clearance (average review time: 103 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under HCG have taken an average of 59 days to reach a decision - down from 104 days historically, suggesting improved FDA processing for this classification.
HCG devices are reviewed by the Neurology panel. Browse all Neurology devices →