Cleared Special

K050700 - MATRIX STRETCH RESISTANT (SR) COILS

K050700 is an FDA 510(k) clearance for MATRIX STRETCH RESISTANT (SR) COILS, manufactured by Boston Scientific Corp. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 28-day FDA review.

K050700 · Boston Scientific Corp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
28d
Days
Class 2
Risk

K050700 is an FDA 510(k) clearance for the MATRIX STRETCH RESISTANT (SR) COILS. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 28 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.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K050700

510(k) Number K050700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2005
Decision Date April 15, 2005
Days to Decision 28 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
120d faster than avg
Panel avg: 148d · This submission: 28d
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 169
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K050700.
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
K051425 · Micro Therapeutics, Inc. · Jun 2005
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
K042297 · Acta Vascular Systems, Inc. · Jun 2005
NEXUS DETACHABLE COIL SYSTEM
K050543 · Micro Therapeutics, Inc. · Apr 2005
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
K042231 · Biocompatibles UK Limited · Nov 2004
GDC-10 360 DEGREE COIL SR
K042539 · Boston Scientific Corp · Oct 2004
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649 · Micro Therapeutics, Inc. · Jul 2004