Cleared Traditional

K112185 - FOURSNARE VASCULAR RETRIEVAL SNARE

K112185 is an FDA 510(k) clearance for FOURSNARE VASCULAR RETRIEVAL SNARE, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K112185 · Cook, Inc. · Cardiovascular device
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Nov 2011
Decision
96d
Days
Class 2
Risk

K112185 is an FDA 510(k) clearance for the FOURSNARE VASCULAR RETRIEVAL SNARE. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 2, 2011 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K112185

510(k) Number K112185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date November 02, 2011
Days to Decision 96 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - MMX Device, Percutaneous Retrieval

All 25
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K112185.
ONE Snare Endovascular Microsnare System
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EN SNARE ENDOVASCULAR SNARE SYSTEM
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TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
K050926 · Idev Technologies, Inc. · May 2005
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · Medical Device Technologies, Inc. · May 2002