Cleared Traditional

K123696 - MEDUSA VASCULAR PLUG

K123696 is an FDA 510(k) clearance for MEDUSA VASCULAR PLUG, manufactured by Endoshape, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K123696 · Endoshape, Inc. · Cardiovascular device
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Oct 2013
Decision
326d
Days
Class 2
Risk

K123696 is an FDA 510(k) clearance for the MEDUSA VASCULAR PLUG. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Endoshape, Inc. (Boulder, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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. Elevated predicate reliance profile. 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 Endoshape, Inc. devices

FDA 510(k) Submission Details - K123696

510(k) Number K123696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date October 25, 2013
Days to Decision 326 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 125d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

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 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K123696.
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