Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242154 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 treatment of cerebral aneurysms. These systems combine detachable coils and a dedicated detachment mechanism to occlude blood flow within aneurysms, reducing the risk of rupture and promoting healing by inducing thrombosis within the aneurysm sac.
The system is supplied as a sterile, single-use device intended for use in interventional radiology or neurosurgery settings. It includes coils and a detachment system compatible with microcatheters, with multiple coil sizes and configurations (as referenced by the FEI numbers) to accommodate various aneurysm morphologies. The device is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD), adhering to Class II classification for neurovascular embolization devices.
Frequently asked questions
What types of medical settings is the Numen Coil Embolization System intended for use in?
The Numen Coil Embolization System is designed for use in interventional radiology or neurosurgery settings. These environments are equipped to handle neurovascular procedures, ensuring the proper deployment of embolization coils for cerebral aneurysm treatment.
Are the coils in the Numen Coil Embolization System single-use or reusable, and how is sterility maintained?
The Numen Coil Embolization System is supplied as a sterile, single-use device. Sterility is maintained through manufacturing processes that ensure each coil and detachment system is packaged and sealed to prevent contamination before use.
How do I determine which coil size or configuration is appropriate for a specific aneurysm?
The system offers multiple coil sizes and configurations, each referenced by FEI numbers (e.g., 1721676, 3012543881). These variations accommodate different aneurysm morphologies, so the appropriate size should be selected based on imaging measurements and the specific characteristics of the aneurysm, such as size, shape, and neck width.
What regulatory pathways does the Numen Coil Embolization System follow, and what does this mean for its use?
The Numen Coil Embolization System is regulated under the FDA 510(k) clearance process and the Medical Device Directive (MDD) in Europe, classified as a Class II device. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and adheres to safety and performance standards, ensuring its suitability for neurovascular embolization procedures.
How is the detachment mechanism in the NumenFR Detachment System integrated with the coils, and what does this imply for procedural workflow?
The NumenFR Detachment System is designed to work seamlessly with the coils, providing a dedicated mechanism for controlled detachment within microcatheters. This integration allows for precise deployment of coils directly into cerebral aneurysms, reducing the risk of premature detachment or misplacement during the embolization procedure.
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 | K242154 | Class II | Active |
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Manufacturer
- Manufacturer
- Microport Neurotech (shanghai) Co., Ltd.
Sources (2)
- FDA 510(k) K242154 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 25, 2026