Cleared Traditional

K021019 - COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE

K021019 is an FDA 510(k) clearance for COTTONY II, manufactured by Genzyme Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K021019 · Genzyme Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
81d
Days
Class 2
Risk

K021019 is an FDA 510(k) clearance for the COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Genzyme Corp. (Fall River, US). The FDA issued a Cleared decision on June 18, 2002 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021019

510(k) Number K021019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date June 18, 2002
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 175
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K021019.
DEMETECH POLYESTER NONABSORBABLE SUTURE
K023030 · Demetech Corp. · Jun 2003
ARTHREX FIBERWIRE IN USP SIZES
K021434 · Arthrex, Inc. · Nov 2002
SAPH-LOOP LIGATING LOOP
K022410 · Genzyme Biosurgery · Aug 2002
SERRALESTER
K020902 · Serral, S.A. DE C.V. · May 2002
LIFESTITCH SUTURING DEVICE
K013990 · Edwards Lifesciences, LLC · Feb 2002
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc. · Oct 2001
K021019 · COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
Download PDF FDA Summary Genzyme Corp.