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)
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.

View all Surgica Corp. devices

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
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 148d · 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 166
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
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · Micro Therapeutics, Inc. · Jan 2004
HYDROCOIL EMBOLIC SYSTEM (HES)
K033836 · MicroVention, Inc. · Dec 2003
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K032590 · MicroVention, Inc. · Oct 2003