Cleared Traditional

K023688 - LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K023688 · LeMaitre Vascular, Inc. · General & Plastic Surgery device
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Jan 2003
Decision
90d
Days
Class 1
Risk

K023688 is an FDA 510(k) clearance for the LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER. Classified as Spatula, Surgical, General & Plastic Surgery (product code GAF), Class I - General Controls.

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on January 30, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all LeMaitre Vascular, Inc. devices

Submission Details

510(k) Number K023688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date January 30, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 114d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAF Spatula, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.