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FDA 510(k)

Numen Coil Embolization System; NumenFR Detachment System

K-Number: K232955 · 2024-01-10

ApplicantMicroPort NeuroTech (Shanghai) Co., Ltd.
Decision Date2024-01-10
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Numen Coil Embolization System; NumenFR Detachment System is a medical device manufactured by MicroPort NeuroTech (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2024-01-10 under approval number K232955. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Numen Coil Embolization System; NumenFR Detachment System?

Numen Coil Embolization System; NumenFR Detachment System is a medical device that received FDA 510(k) clearance on 2024-01-10. It is manufactured by MicroPort NeuroTech (Shanghai) Co., Ltd.. The 510(k) number is K232955.

When was Numen Coil Embolization System; NumenFR Detachment System approved by the FDA?

Numen Coil Embolization System; NumenFR Detachment System received FDA 510(k) clearance on 2024-01-10, under approval number K232955.

What company makes Numen Coil Embolization System; NumenFR Detachment System?

Numen Coil Embolization System; NumenFR Detachment System is manufactured by MicroPort NeuroTech (Shanghai) Co., Ltd..

What is the FDA product code for Numen Coil Embolization System; NumenFR Detachment System?

The FDA product code for Numen Coil Embolization System; NumenFR Detachment System is HCG.

Related Clinical Trials

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Other Devices by MicroPort NeuroTech (Shanghai) Co., Ltd.

K203625Numen Coil Embolization System; NumenFR Detachment System K242154Numen™ Coil Embolization System; NumenFR™ Detachment System

Related Devices (Code: HCG)

K161367HydroCoil Embolic System (HES)MicroVention, Inc. K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160832Penumbra Smart CoilPenumbra, Inc. K160096InZone Detachment SystemStryker Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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