Cleared Traditional

LU-TEX II (K904535) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904535 · Lukens Medical Corp. · General & Plastic Surgery device
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Jan 1991
Decision
118d
Days
Class 2
Risk

K904535 is an FDA 510(k) clearance for the LU-TEX II. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Lukens Medical Corp. (Rio Rancho, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Lukens Medical Corp. devices

Submission Details

510(k) Number K904535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1990
Decision Date January 30, 1991
Days to Decision 118 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAS Suture, Nonabsorbable, Synthetic, Polyester

Devices cleared under the same product code (GAS) and FDA review panel - the closest regulatory comparables to K904535.
ARTHREX BIOWIRE
K091018 · Arthrex, Inc. · Jul 2010
MR-III
K002261 · Smith & Nephew, Inc. · Oct 2000
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · United States Surgical, A Division of Tyco Healthc · Jan 1991
NONABSORBABLE DACRON SURGICAL SUTURE*
K902873 · United States Surgical, A Division of Tyco Healthc · Sep 1990