Numen Coil Embolization System; NumenFR Detachment System
K-Number: K242154 · 2024-09-30
Decision Date2024-09-30
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 2024-09-30 under approval number K242154. 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 2024-09-30. It is manufactured by MicroPort NeuroTech (Shanghai) Co., Ltd.. The 510(k) number is K242154.
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 2024-09-30, under approval number K242154.
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.
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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.