Cleared Traditional

K024090 - NYLON SUTURE

K024090 is an FDA 510(k) clearance for NYLON SUTURE, manufactured by Aurolab. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K024090 · Aurolab · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
79d
Days
Class 2
Risk

K024090 is an FDA 510(k) clearance for the NYLON SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Aurolab (Madison, US). The FDA issued a Cleared decision on February 28, 2003 after a review of 79 days - a notably fast clearance cycle.

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: 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 Aurolab devices

FDA 510(k) Submission Details - K024090

510(k) Number K024090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2002
Decision Date February 28, 2003
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
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 43
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K024090.
NYLON THREADED NEEDLE
K042367 · Aros Surgical Instruments Corp. · Oct 2004
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · Sri Orion Pharmaceuticals & Sutures · Jul 2003
DEMETECH NYLON NONABSORBABLE SUTURE
K023028 · Demetech Corp. · Jun 2003
SERRALNYL
K020146 · Serral, S.A. DE C.V. · Apr 2002
GRAMS NYLON NONABSORBABLE SUTURE
K003000 · Gramsmed, LLC · Dec 2000
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000