Cleared Traditional

K032160 - ARTELON SURGICAL SUTURE

K032160 is an FDA 510(k) clearance for ARTELON SURGICAL SUTURE, manufactured by Artimplant AB. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K032160 · Artimplant AB · General & Plastic Surgery device
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Nov 2003
Decision
125d
Days
Class 2
Risk

K032160 is an FDA 510(k) clearance for the ARTELON SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Artimplant AB (Washington, US). The FDA issued a Cleared decision on November 17, 2003 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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 Artimplant AB devices

FDA 510(k) Submission Details - K032160

510(k) Number K032160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2003
Decision Date November 17, 2003
Days to Decision 125 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 27
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K032160.
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · Aesculap, Inc. · Feb 2016
RiverLon (Nylon) Suture
K152795 · Riverpoint Medical · Oct 2015
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000
MICRINS MICROSURGICAL SUTURE
K993970 · Micrins Surgical, Inc. · Mar 2000
SUTRALON NYLON SUTURES
K994176 · Visionary Medical Supplies, Inc. · Feb 2000