FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Numen Helia Coil Embolization System; NumenFR Detachment System
K Number: K260351
·
Decision May 20, 2026
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
4
Review Days
106
Basic Information
- Device Name
- Numen Helia Coil Embolization System; NumenFR Detachment System
- K Number
- K260351
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroPort NeuroTech (Shanghai) Co., Ltd.
- Date Received
- February 3, 2026
- Decision Date
- May 20, 2026
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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Other Clearances by MicroPort NeuroTech (Shanghai) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242154 | Numen Coil Embolization System; NumenFR Detachment System | Sep 30, 2024 | Substantially Equivalent |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | Jan 10, 2024 | Substantially Equivalent |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | Sep 1, 2021 | Substantially Equivalent |