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Cottony Ii, Silky Ii Polydek & Tevdek Ii Polyester Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021019

by Genzyme Corp.

Identifiers

510(k) Number
K021019 FDA 510(k)
FDA Product Code
GAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5000 FDA 510(k)
Regulation Number
878.5000 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a polyester surgical suture, specifically the Cottony II, Silky II Polydek & Tevdek II variant, indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, orthopedic, and neurological procedures. It is a non-absorbable suture material designed for wound closure and tissue approximation in surgical settings.

The suture is supplied sterile and intended for single-use. It meets United States Pharmacopeia (USP) requirements for non-absorbable surgical sutures, with knot pull values and tensile strength measured according to USP standards. The device received FDA 510(k) clearance under K021019 as substantially equivalent to a predicate device, with product code GAT and review advisory committee SU (General, Plastic Surgery).

Frequently asked questions

What is the Cottony II Silky II Polydek Tevdek II Polyester Suture used for?

This suture is indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, orthopedic, and neurological procedures, as it provides reliable wound closure and tissue approximation in surgical settings.

Is the Cottony II Silky II Polydek Tevdek II Polyester Suture sterile and single-use?

Yes, the suture is supplied sterile and intended for single-use only, ensuring patient safety and preventing cross-contamination during surgical procedures.

What regulatory pathway was used for the Cottony II Silky II Polydek Tevdek II Polyester Suture?

The device received FDA 510(k) clearance under K021019 as substantially equivalent to a predicate device, with product code GAT and review by the General, Plastic Surgery advisory committee (SU).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cottony Ii, Silky Ii Polydek & Tevdek Ii Polyester Suture, Cottony™ II ‹ Teleflex Medical, Suture Options | US | Teleflex

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genzyme Corp.

Sources (1)

  • FDA 510(k) K021019 24 fields · synced Sep 22, 2026