Cleared Traditional

K024091 - SILK SUTURES

K024091 is an FDA 510(k) clearance for SILK SUTURES, manufactured by Aurolab. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K024091 · 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

K024091 is an FDA 510(k) clearance for the SILK SUTURES. Classified as Suture, Nonabsorbable, Silk (product code GAP), 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 878.5030 - 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 - K024091

510(k) Number K024091 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.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 33
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K024091.
MANI NEEDLE & SUTURE PACK (SILK)
K053638 · Mani, Inc. · May 2006
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514 · Sutures India Private Limited · Jun 2005
UNISILK
K042282 · United Medical Industries Co. , Ltd. · Dec 2004
DEMETECH SILK NONABSORBABLE SUTURE
K023029 · Demetech Corp. · Nov 2002
SERRALSILK
K020901 · Serral, S.A. DE C.V. · Apr 2002
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
K012124 · Johnson & Johnson Medical (China) , Ltd. · Sep 2001