Clearance Summary
Numen Helia Coil Embolization System; NumenFR Detachment System received FDA 510(k) clearance under submission number K260351, sponsored by MicroPort NeuroTech (Shanghai) Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-05-20.
- Submission: K260351
- Applicant / Sponsor: MicroPort NeuroTech (Shanghai) Co., Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2026-05-20
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.