Cleared Traditional

K032387 - TRIVEX SYSTEM

K032387 is the FDA 510(k) clearance for TRIVEX SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Cardiovascular device (product code DWQ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K032387 · Smith & Nephew, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
86d
Days
Class 2
Risk

K032387 is an FDA 510(k) clearance for the TRIVEX SYSTEM. Classified as Stripper, Vein, External (product code DWQ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 29, 2003 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K032387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date October 29, 2003
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWQ Stripper, Vein, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
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 - DWQ Stripper, Vein, External

Devices cleared under the same product code (DWQ) and FDA review panel - the closest regulatory comparables to K032387.
PhasTIPP
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