Cleared Special

K232955 - Numen Coil Embolization System (FDA 510(k) Clearance)

Also includes:
NumenFR Detachment System

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232955 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
111d
Days
Class 2
Risk

K232955 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 January 10, 2024 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K232955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

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 K232955.
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