Cleared Special

K032542 - MODIFICATION TO CONTOUR SE MICROSPHERES

K032542 is the FDA 510(k) clearance for MODIFICATION TO CONTOUR SE MICROSPHERES by Boston Scientific Corp. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 29-day FDA review.

K032542 · Boston Scientific Corp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
29d
Days
Class 2
Risk

K032542 is an FDA 510(k) clearance for the MODIFICATION TO CONTOUR SE MICROSPHERES. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Boston Scientific Corp (Glens Falls, US). The FDA issued a Cleared decision on September 16, 2003 after a review of 29 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

Submission Details

510(k) Number K032542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2003
Decision Date September 16, 2003
Days to Decision 29 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
119d faster than avg
Panel avg: 148d · This submission: 29d
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 Peers - HCG Device, Neurovascular Embolization

All 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K032542.
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497 · Micro Therapeutics, Inc. · Sep 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K032553 · Cordis Neurovascular, Inc. · Sep 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · Boston Scientific Corp · Sep 2003
SAPPHIRE DETACHABLE FIBER COILS
K031852 · Micro Therapeutics, Inc. · Aug 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · Micro Therapeutics, Inc. · Jul 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K030963 · Cordis Neurovascular, Inc. · Jun 2003