FDA Product Code NEU: Marker, Radiographic, Implantable
Under FDA product code NEU, implantable radiographic markers are cleared for use in surgical and radiation oncology procedures.
These small metal clips or seeds are placed at the margins of surgical excision sites or tumor beds to provide a permanent radiographic landmark visible on X-ray, CT, and fluoroscopy for post-operative radiation targeting, surveillance imaging, and repeat surgery planning.
NEU devices are Class II medical devices, regulated under 21 CFR 878.4300 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Devicor Medical Products, Inc., Merit Medical Systems, Inc. and Molli Surgical, Inc..
FDA 510(k) Cleared Marker, Radiographic, Implantable Devices (Product Code NEU)
About Product Code NEU - Regulatory Context
510(k) Submission Activity
110 total 510(k) submissions under product code NEU since 2001, with 110 receiving FDA clearance (average review time: 121 days).
Submission volume has increased in recent years - 13 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NEU have taken an average of 172 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.
NEU devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →