Cleared Special

Numen Coil Embolization System; NumenFR Detachment System

K232955 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Neurology

Jan 2024

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K232955 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 January 10, 2024, 111 days after receiving the submission on September 21, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number	K232955 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2023
Decision Date	January 10, 2024
Days to Decision	111 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF