Cleared Special

Numen? Coil Embolization System; NumenFR? Detachment System

K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Neurology

Sep 2024

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K242154 is an FDA 510(k) clearance for the Numen? Coil Embolization System; NumenFR? Detachment System, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by MicroPort NeuroTech (Shanghai) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 30, 2024, 69 days after receiving the submission on July 23, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number	K242154 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2024
Decision Date	September 30, 2024
Days to Decision	69 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF