Cleared Special

K082324 - TRUFILL DCS SYRINGE

K082324 is an FDA 510(k) clearance for TRUFILL DCS SYRINGE, manufactured by Cordis Neurovascular, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 29-day FDA review.

K082324 · Cordis Neurovascular, Inc. · Neurology device
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Sep 2008
Decision
29d
Days
Class 2
Risk

K082324 is an FDA 510(k) clearance for the TRUFILL DCS SYRINGE. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on September 12, 2008 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.

FDA 510(k) Submission Details - K082324

510(k) Number K082324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date September 12, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
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: 149d · This submission: 29d
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
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K080437 · Micrus Endovascular Corporation · May 2008
K082324 · TRUFILL DCS SYRINGE
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