Cleared Special

K010026 - EMBOGOLD MICROSPHERE

K010026 is an FDA 510(k) clearance for EMBOGOLD MICROSPHERE, manufactured by Biosphere Medical, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 169-day FDA review.

K010026 · Biosphere Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K010026

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 149d · This submission: 169d
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 185
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K010026.
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MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
K002056 · Micrus Corp. · Jan 2001
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc. · Nov 2000
K010026 · EMBOGOLD MICROSPHERE
Download PDF FDA Summary Biosphere Medical, In…