Numen Helia Coil Embolization System; NumenFR Detachment System— 510(k) K260351
Substantially EquivalentMicroPort NeuroTech (Shanghai) Co., Ltd.
FDA 510(k) clearance K260351 for Numen Helia Coil Embolization System; NumenFR Detachment System, Substantially Equivalent on 2026-05-20. Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.. Device class: 2.
Summary
MicroPort NeuroTech (Shanghai) filed two items, the Numen Helia Coil Embolization System and the NumenFR Detachment System, under HCG, neurovascular embolization devices.
Class II, 21 CFR 882.5950. Neurology is both the classification panel and the review panel. It came in as a Special 510(k).
MicroPort NeuroTech filed from Shanghai, China. The decision came 106 calendar days after receipt (February 3 to May 20, 2026).
Clearance details
- Applicant
- MicroPort NeuroTech (Shanghai) Co., Ltd.
- Product code
- Product code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shanghai, CN
Recent devices under product code HCG
view allMore clearances from MicroPort NeuroTech (Shanghai) Co., Ltd.
view allAdverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.