Cleared Special

K060625 - NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR

K060625 is an FDA 510(k) clearance for NEXUS DETACHABLE COIL SYSTEM, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 42-day FDA review.

K060625 · Micro Therapeutics, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
42d
Days
Class 2
Risk

K060625 is an FDA 510(k) clearance for the NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on April 20, 2006 after a review of 42 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060625

510(k) Number K060625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2006
Decision Date April 20, 2006
Days to Decision 42 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
107d faster than avg
Panel avg: 149d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 K060625.
M-BOLUS EMBOLIC MICROSPHERES
K052509 · Scion Cardio-Vascular, Inc. · Dec 2006
THE TRUFILL DCS DETACHABLE COIL SYSTEM
K063254 · Cordis Neurovascular, Inc. · Dec 2006
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
K062036 · Micrus Endovascular Corporation · Aug 2006
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K053548 · Protein Polymer Technologies, Inc. · Jan 2006
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
K053197 · Cordis Neurovascular, Inc. · Dec 2005
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
K053160 · Micrus Endovascular Corporation · Dec 2005
K060625 · NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
Download PDF FDA Summary Micro Therapeutics, I…