Cleared Special

EMBOGOLD MICROSPHERE (K010026) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010026 · Biosphere Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
169d
Days
Class 2
Risk

K010026 is an FDA 510(k) clearance for the EMBOGOLD MICROSPHERE. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Biosphere Medical, Inc. (Rockland, US). The FDA issued a Cleared decision on June 21, 2001 after a review of 169 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 Biosphere Medical, Inc. devices

Submission Details

510(k) Number K010026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2001
Decision Date June 21, 2001
Days to Decision 169 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
21d slower than avg
Panel avg: 148d · This submission: 169d
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 184
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K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2024