Cleared Traditional

Numen Coil Embolization System; NumenFR Detachment System

K203625 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Neurology

Sep 2021

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K203625 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 1, 2021, 264 days after receiving the submission on December 11, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number	K203625 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2020
Decision Date	September 01, 2021
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF