Cleared Traditional

K103355 - GDC 360 DETEACHABLE COIL

K103355 is the FDA 510(k) clearance for GDC 360 DETEACHABLE COIL by Boston Scientific Corp. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K103355 · Boston Scientific Corp · Neurology device
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Feb 2011
Decision
92d
Days
Class 2
Risk

K103355 is an FDA 510(k) clearance for the GDC 360 DETEACHABLE COIL. 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 February 16, 2011 after a review of 92 days - within the typical 510(k) review window.

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 Boston Scientific Corp devices

Submission Details

510(k) Number K103355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2010
Decision Date February 16, 2011
Days to Decision 92 days
Submission Type Traditional
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
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K103355.
HYDROCOIL EMBOLIC SYSTEM (HES)
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