Cleared Special

K103008 - INZONE DETACHMENT SYSTEM

K103008 is the FDA 510(k) clearance for INZONE DETACHMENT SYSTEM by Boston Scientific Corp. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 59-day FDA review.

K103008 · Boston Scientific Corp · Neurology device
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Dec 2010
Decision
59d
Days
Class 2
Risk

K103008 is an FDA 510(k) clearance for the INZONE DETACHMENT SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on December 10, 2010 after a review of 59 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.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K103008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date December 10, 2010
Days to Decision 59 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
89d faster than avg
Panel avg: 148d · This submission: 59d
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 104
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K103008.
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