Cleared Traditional

K031531 - S&T MICROSURGICAL SUTURE

K031531 is an FDA 510(k) clearance for S&T MICROSURGICAL SUTURE, manufactured by S & T AG. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K031531 · S & T AG · General & Plastic Surgery device
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Sep 2003
Decision
131d
Days
Class 2
Risk

K031531 is an FDA 510(k) clearance for the S&T MICROSURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by S & T AG (Lake Forest, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 131 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.

FDA 510(k) Submission Details - K031531

510(k) Number K031531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2003
Decision Date September 23, 2003
Days to Decision 131 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 115d · This submission: 131d
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 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K031531.
UNIMIDE
K042284 · United Medical Industries Co. , Ltd. · Dec 2004
NYLON THREADED NEEDLE
K042367 · Aros Surgical Instruments Corp. · Oct 2004
ARTELON SURGICAL SUTURE
K032160 · Artimplant AB · Nov 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · Sri Orion Pharmaceuticals & Sutures · Jul 2003
DEMETECH NYLON NONABSORBABLE SUTURE
K023028 · Demetech Corp. · Jun 2003
NYLON SUTURE
K024090 · Aurolab · Feb 2003
K031531 · S&T MICROSURGICAL SUTURE
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