Cleared Traditional

K103558 - SYNTHES SCOUT VESSEL GUARD (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103558 · Synthes Spine · Cardiovascular device
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Feb 2011
Decision
78d
Days
Class 2
Risk

K103558 is an FDA 510(k) clearance for the SYNTHES SCOUT VESSEL GUARD. Classified as Vessel Guard Or Cover (product code OMR), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes Spine devices

Submission Details

510(k) Number K103558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 02, 2010
Decision Date February 18, 2011
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMR Vessel Guard Or Cover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition These Device Types Do Not Include Devices Whose Primary Purpose Is To Minimize The Incidence Or Severity Of Adhesion Formation As A Result Of Vascular Surgery. Intended To Protect Vessels From Injury During Surgery (not To Be Confused With Wraps, Patches Or Covers Intended To Facilitate Revision Surgeries). Indicated To Wrap, Patch, Or Cover Intended To Cover Blood Vessels.
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.