Numen Helia 1D0115SS
by MicroPort NeuroTech (Shanghai) Co., Ltd.
Numen Helia 1D0115SS is a Class II device made by MicroPort NeuroTech (Shanghai) Co., Ltd., cleared under FDA 510(k) K260351 on 20 May 2026 and listed in FDA GUDID since 15 Jul 2026 (UDI-DI 06958698053898), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06958698053898 | Date15 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260351 | Date20 May 2026 | StatusActive |
Official records
- AccessGUDID record 06958698053898
- FDA 510(k) database K260351
Across registries
- FDA 510(k) K260351 decided 20 May 2026 Active
- FDA GUDID UDI-DI 06958698053898 listed 15 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K260351
- Listed FDA GUDID 06958698053898
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Numen Helia
- Generic name
- Neurovascular embolization coil
- Model / reference
- 1D0115SS
- Primary DI / UDI-DI
- 06958698053898
- 510(k) Number
- FDA product code
- HCG, KRD
- GMDN term
- Neurovascular embolization coil
- Device class
- Class II
- Regulation number
- 882.5950, 870.3300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code HCG (Device, Neurovascular Embolization).
- NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR by Micro Therapeutics, Inc.
- Optima Coil System OPTI0506HSF10 N/A by BALT USA LLC
- Optima Coil System OPTI0620CST10 N/A by BALT USA LLC
- MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V by MICROVENTION INC.
- INZONE M00345100950 451009-5 by Stryker Corp.
- Penumbra LP Coil System by PENUMBRA, INC.
- MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR by Micrus Endovascular Corporation
- CONTOUR SE MICROSPHERES (SYRINGE) by Boston Scientific
- GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES by BIOCOMPATIBLES UK LTD
- MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 by Micrus Corp.
Other devices from MicroPort NeuroTech (Shanghai) Co., Ltd.
See all devices from MicroPort NeuroTech (Shanghai) Co., Ltd. →