Cleared Traditional

MICRUS MICROCOIL SYSTEMS (K073442) - FDA 510(k) Clearance

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

K073442 · Micrus Endovascular Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
81d
Days
Class 2
Risk

K073442 is an FDA 510(k) clearance for the MICRUS MICROCOIL SYSTEMS. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Micrus Endovascular Corporation (San Jose, US). The FDA issued a Cleared decision on February 26, 2008 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micrus Endovascular Corporation devices

Submission Details

510(k) Number K073442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2007
Decision Date February 26, 2008
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
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 Peers - HCG Device, Neurovascular Embolization

All 184
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K073442.
Numen™ Helia Coil Embolization System
K260351 · MicroPort NeuroTech (Shanghai) Co., Ltd. · May 2026
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K254221 · Balt USA, LLC · Jan 2026
Target Detachable Coil
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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