Cleared Traditional

K012145 - MICROPLEX COIL SYSTEM

K012145 is an FDA 510(k) clearance for MICROPLEX COIL SYSTEM, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K012145 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
111d
Days
Class 2
Risk

K012145 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 29, 2001 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. 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.

FDA 510(k) Submission Details - K012145

510(k) Number K012145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2001
Decision Date October 29, 2001
Days to Decision 111 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
38d faster than avg
Panel avg: 149d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCG Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K012145.
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
K020033 · Surgica Corp. · May 2002
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
K014041 · Cordis Neurovascular · Mar 2002
MATRIX DETACHABLE COILS
K012985 · Boston Scientific, Target · Jan 2002
EMBOGOLD MICROSPHERE
K010026 · Biosphere Medical, Inc. · Jun 2001
PVA FOAM EMBOLIZATION PARTICLES
K001678 · Surgica Corp. · Jan 2001
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
K002056 · Micrus Corp. · Jan 2001
K012145 · MICROPLEX COIL SYSTEM
Download PDF FDA Summary MicroVention, Inc.