Numen Coil Embolization System; NumenFR Detachment System— 510(k) K203625

Name: FDA 510(k) clearance K203625
Creator: U.S. Food and Drug Administration
Published: 2021-09-01

Substantially Equivalent

MicroPort NeuroTech (Shanghai) Co., Ltd.

FDA 510(k) clearance K203625 for Numen Coil Embolization System; NumenFR Detachment System, Substantially Equivalent on 2021-09-01. Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.. Device class: 2.

Clearance details

Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2020-12-11
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCG

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K262419 — MICRUSFRAME (19+ models)2026-08-14
K261772 — Target Xtra Detachable Coil2026-06-24
K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
K252694 — Target Detachable Coil2025-12-11

More clearances from MicroPort NeuroTech (Shanghai) Co., Ltd.

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.