# K232955: Numen Coil Embolization System; NumenFR Detachment System

- Pathway: 510(k) (Special)
- Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.
- Decided: Jan 10, 2024 after 111 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K951256 (1995). 44 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203625: Numen Coil Embolization System; NumenFR Detachment System, MicroPort NeuroTech (Shanghai) Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K242154: Numen™ Coil Embolization System; NumenFR™ Detachment System (2024), 1 descendant of its own
- K260351: Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (2026), 0 descendants of its own

## Indications for use
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of: -Intracranial aneurysms -Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae -Arterial and venous embolizations in the peripheral vasculature NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K232955
Methodology: https://510kreport.com/methodology