Cleared Traditional

K171534 - SurgicalPreview

K171534 is an FDA 510(k) clearance for SurgicalPreview, manufactured by Endo Vantage, LLC. The device is a Class 2 Cardiovascular device with product code PZO cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K171534 · Endo Vantage, LLC · Cardiovascular device
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Nov 2017
Decision
167d
Days
Class 2
Risk

K171534 is an FDA 510(k) clearance for the SurgicalPreview. Classified as Software For Visualization Of Vascular Anatomy And Intravascular Devices (product code PZO), Class II - Special Controls.

Submitted by Endo Vantage, LLC (Scottsdale, US). The FDA issued a Cleared decision on November 8, 2017 after a review of 167 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.2050 - 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 Endo Vantage, LLC devices

FDA 510(k) Submission Details - K171534

510(k) Number K171534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date November 08, 2017
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PZO Device Classification - Class 2, Special Controls

Product Code PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning.
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.