Cleared Traditional

K001678 - PVA FOAM EMBOLIZATION PARTICLES

K001678 is an FDA 510(k) clearance for PVA FOAM EMBOLIZATION PARTICLES, manufactured by Surgica Corp.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K001678 · Surgica Corp. · Neurology device
Download Printable Device Report (PDF)
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Jan 2001
Decision
238d
Days
Class 2
Risk

K001678 is an FDA 510(k) clearance for the 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 January 25, 2001 after a review of 238 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgica Corp. devices

FDA 510(k) Submission Details - K001678

510(k) Number K001678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2000
Decision Date January 25, 2001
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 148d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K001678.
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MICROPLEX COIL SYSTEM
K012145 · MicroVention, Inc. · Oct 2001
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
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GDC ULTRASOFT COIL
K002181 · Boston Scientific, Target · Aug 2000
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4
K001083 · Boston Scientific, Target · May 2000