Cleared Traditional

K021019 - COTTONY II

K021019 is the FDA 510(k) clearance for COTTONY II by Genzyme Corp.. It is a Class 2 General & Plastic Surgery device (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)
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.

View all Genzyme Corp. devices

Submission Details

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
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.

Device Classification

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 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K021019.
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K021434 · Arthrex, Inc. · Nov 2002
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K013990 · Edwards Lifesciences, LLC · Feb 2002
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K012923 · Arthrex, Inc. · Oct 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · Aesculap, Inc. · Sep 2001