Cleared Special

K123712 - RETRACTA DETACHABLE EMBOLIZATION COIL

K123712 is the FDA 510(k) clearance for RETRACTA DETACHABLE EMBOLIZATION COIL by Cook Incorporated. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 30-day FDA review.

K123712 · Cook Incorporated · Cardiovascular device
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Jan 2013
Decision
30d
Days
Class 2
Risk

K123712 is an FDA 510(k) clearance for the RETRACTA DETACHABLE EMBOLIZATION COIL. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 3, 2013 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight 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 Cook Incorporated devices

Submission Details

510(k) Number K123712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2012
Decision Date January 03, 2013
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 92
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K123712.
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083 · MicroVention, Inc. · Oct 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · Boston Scientific Corp · Sep 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · MicroVention, Inc. · Jun 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K122543 · MicroVention, Inc. · Nov 2012
AZUR CX DETACHABLE 18
K123384 · MicroVention, Inc. · Nov 2012
AZUR DETACHABLE 35
K122316 · MicroVention, Inc. · Aug 2012