Cleared Special

K102672 - TARGET DETACHABLE COIL

K102672 is the FDA 510(k) clearance for TARGET DETACHABLE COIL by Boston Scientific Corp. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 29-day FDA review.

K102672 · Boston Scientific Corp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
29d
Days
Class 2
Risk

K102672 is an FDA 510(k) clearance for the TARGET DETACHABLE 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 October 15, 2010 after a review of 29 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 K102672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2010
Decision Date October 15, 2010
Days to Decision 29 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
119d faster than avg
Panel avg: 148d · This submission: 29d
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 K102672.
GDC 360 DETEACHABLE COIL
K103355 · Boston Scientific Corp · Feb 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
K103305 · Penumbra, Inc. · Jan 2011
INZONE DETACHMENT SYSTEM
K103008 · Boston Scientific Corp · Dec 2010
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K093973 · Codman & Shurtleff, Inc. · May 2010
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
K100454 · MicroVention, Inc. · Apr 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142 · Boston Scientific Corp · Feb 2010