Cleared Special

K032619 - MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

K032619 is an FDA 510(k) clearance for MICROSTAT PVA FOAM EMBOLIZATION PARTICLES, manufactured by Surgica Corp.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 171-day FDA review.

K032619 · Surgica Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
171d
Days
Class 2
Risk

K032619 is an FDA 510(k) clearance for the MICROSTAT PVA FOAM EMBOLIZATION PARTICLES. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Surgica Corp. (El Dorado Hills, US). The FDA issued a Cleared decision on February 13, 2004 after a review of 171 days - an extended review 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. Standard predicate reliance. 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 - K032619

510(k) Number K032619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date February 13, 2004
Days to Decision 171 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
22d slower than avg
Panel avg: 149d · This submission: 171d
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 K032619.
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649 · Micro Therapeutics, Inc. · Jul 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551 · MicroVention, Inc. · Jul 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694 · Micro Therapeutics, Inc. · Mar 2004
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
K033761 · Biocompatibles UK Limited · Feb 2004
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
K033813 · Micrus Corp. · Feb 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · Micro Therapeutics, Inc. · Jan 2004
K032619 · MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Download PDF FDA Summary Surgica Corp.