Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232955 FDA 510(k)
- FDA Product Code
- HCG FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5950 FDA 510(k)
- Regulation Number
- 882.5950 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Numen Coil Embolization System and NumenFR Detachment System are neurovascular embolization devices designed for the occlusion of cerebral aneurysms and arteriovenous malformations. These systems employ detachable coils and a dedicated detachment mechanism to selectively occlude blood vessels, reducing or eliminating blood flow to abnormal vascular formations.
The system is supplied as a sterile, single-use device intended for use in interventional radiology or neurointerventional procedures. It is classified as a Class II medical device under FDA regulations and adheres to the Medical Device Directive (MDD) in Europe. The coils and detachment system are compatible with MRI environments and come in various sizes to accommodate different anatomical and clinical requirements, with sterilization performed via gamma irradiation.
Frequently asked questions
What clinical conditions is the Numen Coil Embolization System primarily intended to treat, and how does it work?
The Numen Coil Embolization System is designed for the occlusion of cerebral aneurysms and arteriovenous malformations (AVMs). It employs detachable coils and a dedicated detachment mechanism to selectively block blood flow within abnormal blood vessels, effectively reducing or stopping blood supply to these vascular abnormalities. This helps stabilize or eliminate the condition by promoting natural clotting and tissue healing.
Is the Numen Coil Embolization System compatible with MRI imaging, and why does this matter?
Yes, the Numen Coil Embolization System is explicitly stated to be compatible with MRI environments. This compatibility is important because post-procedure imaging often relies on MRI for detailed visualization of the aneurysm or AVM and the placement of the coils, ensuring accurate follow-up and assessment of treatment success without interference from the device.
How is the Numen Coil Embolization System supplied, and what does this mean for clinical workflow?
The system is supplied as a sterile, single-use device, which means each kit is pre-sterilized via gamma irradiation and intended for one-time use only. This design minimizes the risk of cross-contamination between patients and simplifies inventory management, as clinicians do not need to reprocess or sterilize the device after use. It also ensures consistent performance and reliability for each procedure.
What sizes or models are available for the Numen Coil Embolization System, and how does this accommodate different patient needs?
The system comes in multiple sizes, as indicated by the extensive list of FEI numbers (e.g., 3002808761, 3013556777, etc.), which correspond to different coil configurations and diameters. These variations allow clinicians to select the appropriate coil size for specific anatomical requirements, such as the neck width or dome size of an aneurysm or the vascular structure of an AVM, ensuring optimal occlusion and treatment outcomes.
What regulatory pathways has the Numen Coil Embolization System followed, and what does this mean for clinicians or purchasers?
The system has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD) in Europe, indicating it has met stringent regulatory standards for safety and effectiveness. The FDA classification as a Class II device and the specialized clearance route (Special 510(k)) suggest a thorough review process, particularly through the Neurology (NE) advisory committee. This provides purchasers and clinicians with confidence in the device’s compliance with global regulatory requirements, ensuring it meets established performance benchmarks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232955 | Class II | Active |
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Manufacturer
- Manufacturer
- Microport Neurotech (shanghai) Co., Ltd.
Sources (2)
- FDA 510(k) K232955 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026