Cleared Traditional

K203625 - Numen Coil Embolization System (FDA 510(k) Clearance)

Also includes:
NumenFR Detachment System

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203625 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
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Sep 2021
Decision
264d
Days
Class 2
Risk

K203625 is an FDA 510(k) clearance for the Numen Coil Embolization System. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroPort NeuroTech (Shanghai) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 1, 2021 after a review of 264 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all MicroPort NeuroTech (Shanghai) Co., Ltd. devices

Submission Details

510(k) Number K203625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 148d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Biodesign Regulatory Services, LLC
Ivory Chang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 183
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K203625.
Optima Coil System (OptiOne Coil System)
K254221 · Balt USA, LLC · Jan 2026
Target Detachable Coil
K252694 · Stryker Neurovascular · Dec 2025
InZone IST Detachment System
K251832 · Stryker Neurovascular · Oct 2025
Optima Coil System (Optima Packing Coil System)
K252700 · Balt USA, LLC · Sep 2025
Numen™ Coil Embolization System
K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · Balt USA, LLC · Sep 2024