Cleared Traditional

K103355 - GDC 360 DETEACHABLE COIL

K103355 is an FDA 510(k) clearance for GDC 360 DETEACHABLE COIL, manufactured by Boston Scientific Corp. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K103355

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.

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 165
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K103355.
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
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TRAGET DETACHABLE COIL
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MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K103758 · MicroVention, Inc. · Apr 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
K103305 · Penumbra, Inc. · Jan 2011
INZONE DETACHMENT SYSTEM
K103008 · Boston Scientific Corp · Dec 2010
TARGET DETACHABLE COIL
K102672 · Boston Scientific Corp · Oct 2010